Nuth April 2010; We are pleased to share a press release of one of our partners Tryton Medical Inc. TOP Medical has the exclusive distribution rights to sell the Tryton Side Branch stent in the Benelux countries.

Nuth, September 2009:  TOP Medical receives ISO 9001:2008 certificate from KEMA.

From June 2005 TOP Medical is ISO 9001:2000 certified. From September 1st, 2009 TOP Medical is certified based on the new ISO 9001:2008 standard for the Purchase, Sales & Distribution of Medical products and Consultancy activities for Companies within the Medical Field.

The certificate is valid until June 2011.

Please find attached a copy of the certificate.

Nuth, August 2009: We are pleased to announce that TOP Medical signed an exclusive distribution agreement with Cardiatis for the distribution of their Multilayer technology platform in The Netherlands. 

The Multilayer technology platform is the elegant answer to endovascular aneurysm repair. The primary purpose of endovascular aneurysm repair is to prevent death from aneurysm rupture. An aneurysm ruptures when the forces acting on its wall become greater than the wall’s tensile strength.

Cardiatis spatial three dimensional stent design, by virtue of its geometry, slows and laminates blood flow inside the aneurysm minimizing chances of aneurysm rupture and allowing an organized thrombus to form.

Single layer stents have been used clinically to resorb aneurysms. However, their clinical applications have been limited due to the fact that for such effect to happen the stent mesh porosity needs to be so low to such levels that can cause stent rigidity and compromise reach.

Cardiatis 3D Multilayer Braided Stents retain their flexibility at any size since the outer layer in contact with artery wall has high porosity, while the total effective porosity is low as a result of the superposition of two or more braided stent layers.

In-vitro experiments and numerical simulations have shown hemodynamic changes induced by Cardiatis 3D Multilayer Stents leading to reductions of over ninety percent in blood flow velocity within aneurysms. This percentage is two times higher than velocity reduction induced by any commercially available single layer stent.

Nuth, August 2009: We are pleased to post a press release of Cameron Health Inc. TOP Medical has the exclusive distribution rights to sell the S-ICD System in The Netherlands, Belgium and Luxembourg. From September 1st, 2009 TOP Medical start with a controlled launch of the S-ICD System in The Netherlands.

Cameron Health, Inc. announces CE approval for Cameron Health’s Subcutaneous Implantable Defibrillator (S-ICD®) System. The minimally invasive S-ICD System is prescribed for use in patients at risk of Sudden Cardiac Arrest (SCA). The system is unique in that the implantation of the system is entirely subcutaneous; no leads are in or on the heart. Additionally, there is no imaging equipment required for placement of the S-ICD System, as all of the components may be positioned using anatomical landmarks.

Conventional ICD’s require placement of at least one lead in or on the heart. Most frequently, these leads, constructed of thin insulated wires, are threaded through a vein and then placed inside the heart. These conventional transvenous leads allow for sensing of the heart’s rhythm and delivery of a life saving electric shock when a harmful arrhythmia is detected. The surgical placement and residence of these transvenous leads within the patient’s heart are associated with a significant proportion of the complications related to this well established and highly effective therapy. In contrast, the Cameron Health S-ICD System resides just under the skin, potentially avoiding many of the complications associated with the conventional implant procedure and long term performance. The S-ICD System is also designed for ease of placement and removal while shortening the surgical procedure time. The S-ICD System is the first totally subcutaneous implantable defibrillator used to treat SCA. Market launch is scheduled to commence this summer in select geographies as Cameron Health ramps production.

Jay Warren, President and CEO of Cameron Health, Inc. explains, “our goal was to develop a minimally invasive alternative to conventional ICD’s as well as tackle a number of the unmet needs of patients and physicians. We have made a number of significant advances, the foremost being that the Cameron Health S-ICD System obviates the need for transvenous lead placement.”

Commenting on the S-ICD System, Dr. Ian Crozier from ChristChurch in New Zealand said, “This new approach to ICD therapy is better for a significant portion of my ICD patients. The procedure is surgically simple and may reduce or eliminate some of the complexity inherent with transvenous electrodes. For the implanting clinician, not having to wear a protective lead apron to avoid radiation exposure during the procedure was refreshing.”

Darryl Ward, one of the first patients to receive the Cameron Health S-ICD System remarked, “I feel fortunate that this novel technology was available to me because my previous conventional ICD lead was no longer functioning. I just like the idea of nothing needing to be inside my heart anymore.”

About The S-ICD® System

Components of the Cameron Health S-ICD System include the SQ-RX™ Pulse Generator, Q-TRAK™ Subcutaneous Electrode, Q-GUIDE™ Electrode Insertion Tool and the Q-TECH™ Programmer. The S-ICD System is implanted subcutaneously (just under the skin) with the electrode running parallel and slightly to the left of the sternum. While most functions are automatic, adjustments and data retrieval can be easily achieved through a highly advanced integrated programming system developed specifically for the S-ICD System. The Q-TECH programmer is one of the smallest units in the industry weighing less than three pounds. The light weight, portable unit is capable of wireless communication with the SQ-RX Pulse Generator.

Nuth, May 2009; TOP Medical is pleased to announce that Invatec launches the second Drug-Eluting Balloon platform: IN.PACT™ Falcon Targets Coronary Artery Disease

Invatec announced the European launch of a new coronary balloon, the IN.PACT™ Falcon paclitaxel-eluting PTCA balloon catheter. IN.PACT features FreePac™, a proprietary coating that frees and separates paclitaxel molecules and facilitates their absorption into the wall of the blood vessel. In addition to IN.PACT FALCON, Invatec offers a full, dedicated product line for coronary artery treatment, including the Falcon PTCA balloon catheter line, the SKYLOR CoCr stent, the DIVER CE MAX thrombus aspiration device and the TWIN RAIL, a dedicated stent for bifurcation treatment.

Nuth, January 2009: TOP Medical is pleased to post a press release from one of its business partners, Cameron Health, Inc. 

Tuesday January 6, 9:00 am ET San Clemente – (BUSINESS WIRE) Cameron Health, Inc. announces the first CE trial implants in Europe and New Zealand for Cameron Health’s Subcutaneous Implantable Defibrillator (S-ICD®) System. The minimally invasive S-ICD System is prescribed for use in patients at risk of Sudden Cardiac Arrest (SCA). The system is unique in that the implantation of the system is entirely subcutaneous; no leads are in or on the heart. Additionally, there is no imaging equipment required for placement of the S-ICD System, as all of the components may be positioned using anatomical landmarks.
Conventional ICD’s require placement of at least one lead in or on the heart. Most frequently, these leads, constructed of thin insulated wires, are threaded through a vein and then placed inside the heart. These conventional transvenous leads allow for sensing of the heart’s rhythm and delivery of a life saving electric shock when a harmful arrhythmia is detected. The surgical placement and residence of these transvenous leads within the patient’s heart are associated with a significant proportion of the complications related to this well established and highly effective therapy. In contrast, the Cameron Health S-ICD System resides just under the skin, potentially avoiding many of the complications associated with the conventional implant procedure and long term performance. The S-ICD System is also designed for ease of placement and removal while shortening the surgical procedure time. When approved, the S-ICD System will be the first totally subcutaneous implantable defibrillator used to treat SCA.
Jay Warren, President and CEO of Cameron Health, Inc. explains, “The technological advancements with the Cameron Health S-ICD System are designed to provide patients with a safe, minimally invasive alternative to conventional ICD’s. Since the Cameron Health S-ICD System is placed by anatomical landmarks, there is no need for expensive imaging equipment.”
Fourteen patients have received an S-ICD System as part of the CE trial, which will involve up to 55 patients at 10 centers in Europe and New Zealand. Implants performed in New Zealand were conducted by Dr. Margaret Hood at Auckland City Hospital and by Dr. Ian Crozier at Christchurch Hospital. Initial implants in Europe were under the direction of Dr. Riccardo Cappato at Policlinico San Donato Milanese Hospital in Italy and Professor Luc Jordaens at Erasmus Medical Center in the Netherlands.
Commenting on the clinical trial and the first CE trial patient to receive the S-ICD System in New Zealand, Dr. Hood said, “Our initial experience with this new technology has brought positive results. The whole procedure was surgically simple. Once implanted, the S-ICD System can be programmed to automatically optimize the device parameters for monitoring the heart’s rhythm while removing some of the complexity inherent in conventional systems. Not having to wear a protective lead apron to avoid radiation exposure during the procedure was refreshing. All patients have returned to their normal routines and are doing well.”
Darryl Ward, one of the first patients to receive the Cameron Health S-ICD System remarked, “I feel fortunate that this novel technology was available to me because my previous conventional ICD lead was no longer functioning. I just like the idea of nothing needing to be inside my heart anymore.”
About The S-ICD® System
Components of the Cameron Health S-ICD System include the SQ-RX™ Pulse Generator, Q-TRAK™ Subcutaneous Electrode, Q-GUIDE™ Electrode Insertion Tool and the Q-TECH™ Programmer. The S-ICD System is implanted subcutaneously (just under the skin) with the electrode running parallel and slightly to the left of the sternum. While most functions are automatic, adjustments and data retrieval can be easily achieved through a highly advanced integrated programming system developed specifically for the S-ICD System. The Q-TECH programmer is one of the smallest units in the industry weighing less than three pounds. The light weight, portable unit is capable of wireless communication with the SQ-RX Pulse Generator.
About Sudden Cardiac Arrest
Sudden Cardiac Arrest (SCA) is a sudden, abrupt loss of heart function. Most SCA episodes are caused by the rapid and/or chaotic activity of the heart known as Ventricular Tachycardia or Ventricular Fibrillation. Recent estimates show that approximately 850,000 people in the U.S. are at risk of SCA and indicated for an ICD device, but remain unprotected. In fact, less than 35 percent of patients who are indicated for an ICD receive one. SCA is not the same as a heart attack. A heart attack is a malfunction caused by blockage in a vessel that supplies blood to the heart, which may permanently damage part of the heart. Unlike SCA, most people survive a first heart attack. SCA is an “electrical” malfunction of the heart that results in no blood flow to the body or the brain. SCA is 95 percent fatal if left untreated. ICD’s are proven to be 98 percent effective in treating dangerous heart rhythms that can lead to SCA.
About Cameron Health, Inc.
Cameron Health, Inc. (www.cameronhealth.com), headquartered in San Clemente, California, is a pioneer in the development, manufacture and distribution of the next generation of implantable defibrillators.

Nuth, January 2009: On January 1st TOP Medical went live with the SAP solution for Life Sciences. 

The SAP's Life Sciences platform enable TOP Medical to drive superior performance from supplier to customer with regards to product and portfolio management, clinical trial supply management, complaint management and financial management.

With this initiative TOP Medical reconfirms its commitment to support its customers to optimize performance in the process from product idea to patient treatment.

You can read more about this in the attached pdf file (Dutch article) which you find under the "more" button.

Nuth, February 2009: TOP Medical is pleased to post a press release from one of its business partners, Invatec.

Invatec announced the European launch of a new peripheral balloon, the IN.PACT™ Amphirion paclitaxel-eluting PTA balloon catheter. This is the first drug-eluting balloon catheter, designed specifically to treat atherosclerosis in arteries located below the knee (BtK). IN.PACT features FreePac™, a proprietary coating that frees and separates paclitaxel molecules and facilitates their absorption into the wall of the blood vessel. Invatec plans to launch a randomized trial, the IN.PACT DEEP study during the current calendar year quarter, to provide additional data about the effectiveness of this new therapeutic concept. In addition to IN.PACT Amphirion, Invatec offers a full, dedicated product line for below the knee artery treatment, including the Amphirion™ DEEP 0.014" balloon catheter, the 0.014" Skipper™ DEEP guide wire, the Chromis™ DEEP 0.014" balloon-expandable stent and the Maris™ DEEP 0.018" self-expandable stent.

Nuth, January 2009: On January 8th TOP Medical opened its new warehouse.

The new warehouse is located beside the TOP Medical office in Nuth and is built in line with the latest requirements for Medical Device storage.  

With this new warehouse TOP Medical increased its capability to support logistic activities for its business partners.

 

Nuth, January 2009: TOP Medical is pleased to post the below mentioned press release of one of its partners, Concentric Medical Inc.
MOUNTAIN VIEW, CA, January 26, 2009 --- Concentric Medical, Inc., the global leader in devices for clot removal in ischemic stroke patients, today announced that the Company’s Merci Retrieval System™ has been used in over 10,000 patients since its launch in August 2004. The Merci Retrieval System is a catheter-based medical device that advanced stroke centers use to remove blood clots from patients suffering an ischemic stroke. The Merci Retrieval System has been used by leading stroke institutions around the world. In commenting on this accomplishment, Dr. Marilyn Rymer, Medical Director at Saint Luke’s Mid-America Brain and Stroke Institute in Kansas City, MO, said, “This milestone marks a great achievement in the advancement of interventional stroke care both in the U.S. and around the world. At Saint Luke’s Hospital in Kansas City, we have used the device in over 300 stroke victims, old and young, with very impressive results. Concentric Medical and the Merci Retrieval System have revolutionized the way we treat stroke.” Concentric Medical has brought to market three generations of Merci Retrievers®, and worked very closely with the stroke care community in conducting two important clinical trials. Dr. Gary Duckwiler, Director of Interventional Neuroradiology at UCLA’s David Geffen School of Medicine, commented, “It is incredible to think that in such a short time, with such a difficult and devastating disease, that 10,000 patients have been treated with Merci® devices. I remember the first case we did using the original Merci device, a success that told us we could make a significant difference in acute stroke care. Concentric Medical has dramatically altered the treatment landscape for acute stroke by making it possible for Stroke Centers to fulfill their promise of improving patient’s lives. Concentric Medical should be congratulated on its tremendous accomplishments.”
Over 780,000 strokes occur in the U.S. alone each year. Stroke is the third leading cause of death and a leading cause of adult disability in the U.S. Stronger coverage by neurointerventionalists, increased patient awareness and faster development of comprehensive stroke center capabilities are all key components to ensuring these patients have access to high quality stroke care, including the Merci Retrieval System. A milestone like this is only possible with close collaboration between industry and clinicians. It marks the closing of an initial phase in the development of a new therapy while opening an even more important phase to drive broad global adoption. “We are at the forefront of change in interventional stroke care,” said Concentric Medical’s President and Chief Executive Officer, Maria Sainz. “Concentric Medical is committed to bringing forward advancements in stroke intervention through ongoing clinical study and product innovation to broaden the reach of this breakthrough technology to stroke patients.”

Nuth, November 2008; TOP Medical signed an agreement with Swissimplant AG to distribute their Solysafe Septal Occluder for minimal invasive closure of ASD and PFO.

The Solysave Septal Occluder uses a unique design that was developed to maximise security and to give the physician more control during the whole procedure. It is the only guidewire-based septal occluder that is deployed without the necessity of a long transseptal sheat. The innovative delivery system allows the independent control of the left and right atrium disks and offers the physician more possibilities in the placement of the device. The self-centring mechanism and the flat profile, among many other features, make the Solysafe Septal Occluder a good alternative to other devices.

 

Nuth, October 2008: Tryton Medical Inc., a developer of novel stent systems for the treatment of cardiovascular disease, announced today that the company has initiated launch of its novel Side Branch Stent System™ in Europe.

Tryton's Side Branch Stent System is designed to offer a dedicated strategy for treating atherosclerotic lesions at the site of a bifurcation. The system will be available first in the Netherlands, with additional European countries to follow in the coming months. TOP Medical has partnered with Tryton to distribute the device in the Netherlands.

"We are extremely pleased that our Side Branch Stent System is now available to patients and physicians in the Netherlands," said J. Greg Davis, president and CEO of Tryton Medical. "We are excited about the benefits that our technology promises for patients with cardiovascular disease in Europe. We plan to launch in additional countries soon. We also look forward to initiating a multi-center prospective study evaluating the Tryton Side Branch Stent in real-life practice in the coming weeks."

Cardiovascular disease causes nearly half of all deaths in Europe, claiming 4.3 million lives annually. Approximately twenty percent of patients treated for coronary artery disease are treated for bifurcated lesions.

Bifurcation lesions have presented a challenge for cardiologists since the earliest days of angioplasty. Current approaches to treating these lesions have significant limitations. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation.

"The Tryton Side Branch Stent System, which has demonstrated excellent initial clinical results, offers an innovative solution to a persistent problem in the interventional treatment of patients with complex coronary lesions," said Prof. Antonio L. Bartorelli of the Centro Cardiologico Monzino at the University of Milan, who attended today's European Bifurcation Club meeting in Prague where the launch was announced. "I am pleased that this highly deliverable side-branch stent is now available as a treatment option for these difficult-to-treat cases."

The Tryton Side Branch Stent System is used in conjunction with a conventional drug-eluting stent.

About the Tryton Side-Branch Stent System

The Side Branch Stent System is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. These areas of the vascular system are a common location for plaque and are particularly challenging to treat with currently available stent systems. Approximately twenty percent of patients treated for coronary artery disease are treated for bifurcated lesions.

Tryton's highly deliverable cobalt chromium stent is deployed in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug eluting stent is then placed in the main vessel.

The Tryton Side Branch Stent System demonstrated excellent six-month clinical results in a first-in-man study of the system in 30 patients, with no restenosis occurring in the side-branch artery. The stent system has received CE Mark approval in Europe and is not approved in the United States.

About Tryton Medical, Inc.

Tryton Medical, Inc., located in Research Triangle Park, N.C., is a leading developer of novel stent systems for the treatment of bifurcation lesions. The company's Side Branch Stent System is designed to offer a dedicated strategy for treating these challenging cases, which occur in approximately twenty percent of patients treated for coronary artery disease. The privately held company is backed by Spray Ventures, PTV Sciences, RiverVest Ventures.

Nuth, September 2008; TOP Medical launched Invatec's new peripheral self-expanding stent system, the MARIS DEEP. The product completes Invatec's DEEP portfolio that features dedicated devices for lower limb treatment, particularly in smaller vessels.

The MARIS DEEP sets new standards in deliverability due to a 3.7F braided shaft design that allows for 4F introducer sheat compatibility for all sizes. The size offering ranges from 3.0 mm to 6.0 mm allowing vessels as small as 2.0 mm to be stented. Invatec is also the first company to offer 80 mm long stents for all portfolio diameters, thus avoiding the need for overlapping stent placements in long lesions.

Beside the MARIS DEEP Invatecs DEEP program also offers the Amphirion DEEP 0.014" balloon, the Skipper DEEP 0.014" guide wire and the Chromis DEEP 0.014" Balloon-expanding Cobalt Chromium stent.

Nuth, June 2008: Two days before its 5th anniversary TOP Medical received the prolonged ISO 9001-2000 certificate from the Accredited Unit of Det Norske Veritas Certification B.V., The Netherlands. 

From June 2005 DNV has found TOP Medical to conform to the Management System Standard of NEN-EN-ISO 9001:2000 for the Purchase, Sales & Distribution of Medical products and Consultancy activities for Companies within the Medical Field. The certificate is valid until June 2011. 

Please find attached a copy of the certificate.

Nuth, August 2008; Tryton Medical, Inc. achieved a major medical milestone in stent technology with unprecedented six-month clinical and angiographic results from the Tryton 1 (First-In-Man Study). Dr. Ralf Müller (Helios Heart Center, Siegburg, Germany) and Professor Patrick W.J.C. Serruys (Erasmus Medical Center, Rotterdam, the Netherlands) presented the clinical and angiographic results at the European Bifurcation Club Meeting in Valencia, Spain. The Tryton Side-Branch StentTM was used in conjunction with a standard drug eluting stent to treat 30 patients with coronary blockages involving large side-branches. After 6 months, none of the patients suffered from side-branch restenosis (blockage of the artery). Core laboratory quantitative analysis reported a late loss of 0.27 ± 0.42 mm in the side branch and 0.12 ± 0.47 mm in the main vessel. “The Core Angiographic Data demonstrates that the hybrid approach, bare metal Tryton Side-Branch Stent used in conjunction with a standard drug eluting stent, provides the same type of restenosis reduction we have seen when drug eluding stents are used to treat standard lesions,” said Professor Serruys, Erasmus Medical Center, the Netherlands. “This is the first time, I have seen such promising results in the treatment of bifurcation disease,” added Serruys. “The ability to treat bifurcation lesions has been a problem confronting us since the first days of angioplasty”, said Dr. Ralf Müller, Helios-Heart Center, Germany. “Tryton seamlessly integrates with other aspects of the angioplasty/stent procedure, allowing interventional cardiologists to treat this challenging patient subset with a high level of predictability and ease. The data shows that Tryton’s approach is not only safe, but it reduces restenosis to acceptable levels. I can now treat with confidence, this problem which I confront in nearly 20% of my cases,” Müller added. “To establish Tryton as the gold standard of care for the treatment of bifurcation lesions, ryton’s product must be easy-to-use and reduce estenosis to acceptable levels. The results from our First-In-Man Study demonstrate that Tryton meets both criteria,” said H. Richard Davis, CTO, Tryton Medical, Inc. Every year, over half a million bifurcation coronary lesions are sub-optimally treated as no commercially available optimized solution exists for treating bifurcation lesions. As a result, cardiologists are forced to use a provisional strategy which avoids the deployment of a second stent-- leaving the side branch vulnerable to thrombosis and restenosis. “This technology has the capacity to redefine the treatment of bifurcation lesions and resolve a frequent dilemma of the interventional cardiologist,” said Professor Patrick W. J. C. Serruys, M.D., Head of the Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.

Nuth, February 2008; TOP Medical  launched the Falcon Bravo, the world’s smartest PTCA balloon catheter – with top level features for daily routine. A wide range of sizes guarantees a large variety of possibilities for standard procedures with the typical falcon family benefits: The concept of a tapered elongated “sensor” tip design enhances lesion crossing and controlled steering sensity of the tip, while the “Bikini” coating guarantees stable positioning for focal dilation. The stepless transition from Hypotube to balloon tip guarantees a congruent pushability from finger to catheter- tip and a 1:1 push response and the fixed inner tube prevents accordion effects during multiple re-crossing passages. The new special balloon material provides a high flexibility without compromising RBP with the ideal combination of pressure resistance and compliance.

Nuth, February 2008; Concentric Medical, Inc., the global leader in devices for clot removal in ischemic stroke patients, today announced that results from the use of its Merci Retrieval System™ were featured and discussed in seventeen separate presentations at the International Stroke Conference held in New Orleans, Louisiana, February 20-22, 2008.
Positive clinical and economic results from the use of the Merci Retrieval System in patients suffering from acute ischemic stroke were discussed during five main podium presentations and more than 12 poster sessions over the three-day conference, which had more than 3,500 people in attendance.
And for the first time, a study performed at the University of California, San Francisco Medical Center confirmed the positive economic impact of successfully restoring blood flow with the Merci Retriever®. According to the American Stroke Association, stroke is estimated to cost the U.S. health care system in excess of $63 billion per year.
“The prevalence of the Merci Retrieval System at important scientific meetings like the International Stroke Conference is very gratifying”, said Gary Curtis, President and CEO of Concentric Medical. “It underscores the progress Concentric has made in making the Merci
Retrieval System a front-line approach to revascularizing patients with acute ischemic stroke.” As the first device cleared by the U.S. Food and Drug Administration for retrieval of clot in patients suffering from acute ischemic stroke, the Merci Retrieval System has been used on over 7,000 patients worldwide, making the Merci Retrieval System the most clinically accepted device of its kind.

Nuth, February 2008, TopSpin Medical, Inc. announces first commercial installation of the Cathamaran(TM) Intravascular MRI System at ZOL Hospital, Genk, Belgium, with the first procedures performed on January 16th.

"We are pleased to be the first site to install the Cathamaran(TM) IVMRI System. This 6F compatible technology represents a major breakthrough in our ability to detect and quantify lipid present in coronary lesions. We are very excited to be among the first centers to participate in the MIRACLE Study to further evaluate the clinical role for IVMRI in both diagnostic and interventional coronary catheterization procedures. The identification of high risk, lipid -rich lesions that may be prone to rupture is of paramount importance, and the IVMRI System may potentially help address this unmet need," stated Dr. M. Vrolix from ZOL hospital, Belgium.

The company and distributor TOP Medical are currently in advance negotiation for similar agreements with additional medical centers in the Benelux territory. The company is expecting to install additional Cathamaran(TM) Intravascular MRI systems in the Benelux territory in the course of the current quarter.

The Cathamaran(TM) IVMRI System will be used in a post-market Study of coronary plaque lipid characterization by IVMRI performed during diagnostic or interventional catheterization [MIRACLE Study]. The multi-national prospective MIRACLE Study is designed to collect data on a widespread post-market clinical experience to evaluate how lipid quantification with the IVMRI System may be used to guide patient treatment.

Yaron Tal, President and Chief Executive Officer of TopSpin Medical, said: "The introduction of our unique Cathamaran(TM) Intravascular MRI System and the initiation of the MIRACLE Registry represent major milestones for our company. We are committed to advancing investigation into vulnerable plaque with the goal of improving diagnosis of these high-risk lesions and aiding development of appropriate therapeutic solutions. We are very excited to collaborate with ZOL hospital in this important investigation."

Nuth, January 2008:  LEONARDO - Clinical Evaluation of a Last Generation Coronary Stent in a Real World Typical Non-DES Population – A Prospective, Single-Center Registry by Dr. J.J. Koolen from Catharina Hospital Eindhoven, NL. Published in Interventional Cardiology 2007.

Background: Drug Eluting Stents (DES) decrease angiographic and clinical restenosis compared to Bare Metal Stents (BMS) but don't reduce the rate of mycardial infarction and cardiac death. The benefit of DES has been demonstrated mainly in comparison to old fashioned BMS and in selected subsets of patients. Accordingly, a remarkable portion of patients with coronary artery disease may nowadays benefit from new generation BMS.

Methods: A new closed cell, thin strut Cobalt Chromium stent (Invatec Skylor CoCr stent) was used in a prospective single center registry. Between August 2005 and June 2006, consecutive patients with stable or unstable coronary artery disease candidate for Percutaneous Coronary Interventions (PCI) with BMS were enrolled. Patients were considered eligible for non-DES stenting if they had an Acute Myocardial Infarction (AMI) or if they had coronary lesions at low-medium risk of restenosis (large vessles, no long lesions, no complex lesions). Pre-PCI and Post-PCI quantitive coronary angiography (QCA) was performed off line. Clinical outcome up to 6-months was prospectively assessed.

Results: 150 patients were successfully treated with the investigational BMS during the study period. Mean reference vessel diameter was 3.05 mm (+/_  0.31 SD). Mean lesion length was 15.19 mm (+/- 6.40 SD). The rate of diabetic patients was 5.33% and the rate of patients with AMI was 22.00%. All patients underwent 6-month clinical follow-up. Hierarchial count showed MACE (Major Adverse Cardiac Event) rate at 6 months of 4.00%: There were 2 (1.33%) cardiac deaths, 1 (0.67%) AMI and 3 (2.00%) clinicallly driven Target Lesion Revascularization (TLR).

Conclusions: selective adoption of latest generation bare metal Co-Cr stents in fairly un-complex angiographic settings result in a very low MACE and TLR rate. The benefit of DES in such real world daily cases may not be cost effective neither beneficial. Further studies are needed to support this statement.

Nuth, February 2008; TOP Medical launches the Merci L4 and Merci L6 Retrievers®  from Concentric Medical for use in Stroke Patients.

These new Retrievers, released in the United States in 2007, join the existing Merci Retrievers® already on the market in Europe, and provide physicians with additional choices in their efforts to restore blood flow in ischemic stroke patients.

The Merci L4 and L6 Retrievers join Concentric Medical’s L family of Retrievers which incorporate filaments into the retrieval helix. These filaments provide an additional mechanism for securing blood clots during retrieval from the brain. The Merci L6 Retriever has a 2.7 mm cylindrical helix and is designed for use in larger vessels than the Merci Retrievers currently on the European market. The Merci L4 Retriever has a 2.0 mm cylindrical helix and is designed for use in smaller vessels, further adding to the Merci Retriever portfolio. 

"The Merci Retrieval System™ has been used on many more ischemic stroke patients than any other clot retrieval system, and we continue to incorporate the knowledge gained from this experience into improved devices,” said Gary Curtis, President and CEO of Concentric Medical. "These next generation Retrievers are further evidence of our leadership in bringing exciting and new life saving options to stroke patients.”

The Merci Retriever is a shaped wire constructed of nitinol, a “memory wire,” that allows delivery of the Retriever in linear form using standard catheterization techniques. A small puncture in the groin is used to introduce the Merci Retriever into an artery leading to the brain. Upon reaching the targeted area, the Merci Retriever is deployed and returns to its original helical shape. The Merci Retriever is designed to restore blood flow by engaging, capturing and removing blood clots.

Nuth, October 2007: TopSpin Medical (TASE: TOPMD) announced that the 30-day results from the multicenter prospective study of the TopSpin Intravascular Magnetic Resonance Imaging System During Coronary Endovascular Catheterization (TOPIMAGE) demonstrated the safety and technical procedure success for the IntraVascular MRI (IVMRI) catheter in the coronary arteries. The study enrolled a total of 104 patients contributed from 10 centers in the US, Europe and Israel. Martin Leon, MD, of Columbia University Medical Center, New York, NY, and Co-Principal Investigator of the TOPIMAGE study, presented the study results at the Transcatheter Cardiovascular Therapeutics (TCT) 2007 Scientific Symposium in Washington DC. 

“This study showed that the novel self-contained IVMRI system is feasible for use in the cardiac catheterization lab setting. We are pleased with the clinical results to-date, and we are enthusiastic to expand the clinical evaluation of the System,” said William Wijns, MD, of Onze-Lieve-Vrouw Hospital, Aalst, Belgium, and Co-Principal Investigator of the Study.

The Company also announced that it has recently submitted a 510K application to the US FDA, which included the compiled TOPIMAGE results, as a required step toward obtaining marketing clearance for its IVMRI System in the US.

“Completion of the TOPIMAGE study and submission of 510K marketing application are major milestones for the Company and represent the culmination of several years of research and development. We believe that IVMRI will become a very beneficial diagnostic tool for early detection and guidance of treatment for high risk coronary plaques,” said Yaron Tal, CEO of TopSpin Medical.

The TOPIMAGE study was designed to assess device safety and functional performance of the IVMRI System in patients undergoing cardiac catheterization. The primary endpoint of the study was the incidence of major adverse cardiac events (MACE) at 24 hours. The incidence of MACE at 24 hours was only 0.96% (1 patient), and at 30 days was 1.9% (1 additional patient). There were no deaths and no perforations. Performance success was achieved in 88%, and at least one IVMRI measurement was obtained in 95% of patients.

Rupture of coronary plaque with subsequent thrombus (blood clot) formation is the underlying cause of most acute coronary syndromes (ACS). Early reliable assessment of lipid- rich vulnerable plaques near the surface of the arterial wall may lead to more aggressive treatment of coronary artery disease and reduce the overall incidence of myocardial infarction (heart attack) and death. TopSpin’s IVMRI catheter is the first device designed for percutaneous intravascular imaging and characterization of the tissue lipid composition of coronary plaque during a conventional cardiac catheterization procedure. The IVMRI catheter is designed to measure the lipid content within the target plaque.

Nuth, September 2007: Concentric Medical is a medical device company that designs, develops and markets products for restoring blood flow in patients who have suffered ischemic strokes, which result from blood clots in the vessels of the brain. The Merci Retrieval System is designed to restore blood flow in the neurovasculature of ischemic stroke patients by removing blood clots. In 2004, it received clearance from the U.S. Food and Drug Administration, or FDA, for this indication, and the system is the only such FDA cleared device. It has also received FDA clearance to market the device for use in the retrieval of foreign bodies misplaced during the interventional radiological procedures in the neuro, peripheral and coronary vasculature. We believe that the Merci Retrieval System offers an option for ischemic stroke patients, who historically have had few other treatment options available. We estimate that over 6,000 patients have been treated to date with the Merci Retrieval System. Within the Netherlands there are sofar 4 hospitals equiped with this technology.

Nuth, September 2007: TOP Medical launced at the Cirse in Athens the Scuba Cobalt Chromium Peripheral Stent from Invatec. The Scuba is the first Cobalt Chromium Peripheral Stent System with unlimited deliverability and flexibility, even in contralateral approaches. The closed and diameter specific cell design enable a predictable scaffolding and appropriate radial force.

Nuth, August 2007: Over the last years TOP Medical supported start-up as well as corporate companies with their European clinical activities. Recently we decided to establish an independent division for these Clinical Trial Services managed by Annemieke van de Weyer. Within this division we assists our partners in all stages of the clinical trial process as site selection, submission to ethics committees, study initiations, clinical & technical support, monitoring, device accountabilitsy and logistics.
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Nuth, June 2007: The Relay Thoracic Stent-Graft & Transport Delivery System is the next generation stent-graft specifically designed for aortic arch applications and long-term deliverability. The Freeflex Technology creates independent articulation of the primary sealing & fixation zone, allowing it to orientate itself independently of the secondary sealing & fixation zone and the rest of the stent graft. This feature provides safe and secure fixation and sealing plus 3Dimensional conformance. The spiral support strut is the perfect balance of multi-directional flexibility and column strength. Acting as a shock absorber, the spiral support strut absorbs the natural forces with the aorta eliminating a focal stress point.

Nuth, October 2006: TopSpin Medical has developed an IntraVascular MRI (IVMRI) catheter for local high-resolution MR imaging of the coronary arteries, which incorporates all magnetic field sources and eliminates the need for external magnets and a bulky and expensive MRI scanner. TopSpin's IVMRI catheter will potentially enable interventional cardiologists to guide therapy to vulnerable plaques.

Nuth, May 2006: CathRX is a specialized Australian medical devices company initially focusing on the development and commercialization of a range of innovative cardiac catheters for use in the diagnosis and treatment of electrical problems of the heart known as cardiac arrhythmias.

Nuth, January 2006: Due to excellent characteristics of the Co-Cr stent material, the SKYLOR cobalt-chrome coronary stent combines good visibility, thin struts, minimal passage profile and high radial strength. The newly designed RX-segment with an adjusted nitinol wire enables an optimal passage from a high pushability of the hyper tube shaft to the complete flexibility of the distal catheter. The new balloon material FLEXITEC™ Ultra of the stent delivery system assures highest flexibility and a low passage profile with semi compliance. The struts, 80 micron thin, contribute to an ultra thin passage profile for a safe success in an ambitious anatomy. The closed cell design offers a stable, reliable and permanent homogeneous scaffolding, no matter what kind and curve of the lesion. The Tight-Fix™ crimping technology enables a secure stent fixation to the balloon, even at difficult passages in curved anatomy.