Cape Town, July 15th, 2010; It is a pleasure to announce that TOP Medical signed an exclusive Distribution Agreement with DISA Vascular for The Netherlands, Belgium and Luxembourg.

DISA Vascular is an innovative medical device company that specializes in vascular technology for the treatment of coronary artery disease. Situated in Cape Town, South Africa, the company has been developing stents for the international market since its inception in 1999, in the process, realizing its vision of Bringing Quality to Life.

DISA Vascular has spent the past twelve years building on this legacy. Through in-depth research and development and a total commitment to patient care, the company has produced high quality innovative medical devices for the treatment of coronary artery disease.

Today their products are sold via a network of distributors in many parts of the world and through a direct sales force in South Africa. DISA Vascular has ISO9001 and ISO13485 European certifications.

Looking ahead, the CEO of DISA Vascular, Greg Starke aims to take DISA up to what he terms a “tier two company – just below the ‘big four’” in five year’s time. That will mean broadening the product range, growing the company’s global footprint from ten to 25 countries and establishing a physical presence in Europe, DISA’s biggest growth market. 

TOP Medical is proud to partner with DISA Vascular and support them in reaching their goals within Europe and beyond.

Nuth, July 2010; We are pleased to publish an article of one of our Partners, Advanced Cardiac Therapeutics. 

Objectives: A novel technology for radiofrequency catheter ablation (RFCA) has been designed to maximize the effectiveness and accuracy of ablation therapy. The irrigated Tempasure™ temperature-sensing catheter has a chip based instrumented tip which measures and interprets microwaves emitted from heated tissue during RFCA in order to measure temperature at depth in the tissue treated.

Background: RFCA is the standard of care in the treatment of patients with arrhythmias. Ablation systems allow for temperature-controlled energy delivery and rapidly curtail energy delivery for an impedance rise. Irrigated saline-cooling of the distal electrode helps minimize impedance rises but interferes with the ability of the thermistor at the tip of the electrode to record temperature at the tissue level. Innovative catheters based on microwave radiometry measurements are not affected by saline-cooling and are able to accurately evaluate tissue temperature and ablation lesion volume
during irrigated RF ablation. 

Summary: Microwave radiometry technology allows the electrophysiologist real-time feedback on catheter-tissue contact, and temperature at 3 mm depth in tissue. Providing complete control of the lesion formation with an irrigated ablation catheter enables the operator to confidently plan and control the lesions — the definitive key to performing safer, more effective procedures.

Nuth, May 31st, 2010

Dr. Van Opstal from the Maastricht University Medical Centre performed today the first Transseptal puncture in the Benelux with the Bayliss NRG RF Transseptal Needle.

It concerned a 43 year old women with recurrent tachycardias since a couple of years. On the ECG a clear delta wave indicating a left lateral accessory pathway which was confirmed during electrophysiological study .

A rather floppy interatrial septum was present but the transseptal puncture with the Bayliss NRG RF Transseptal Needle went safe within 2 seconds.

After inducing the tachycardia and mapping, the accessory pathway was ablated by one radiofrequency application .

Baylis Medical is committed to the development and commercialization of the new NRG RF Transseptal Needle to cross the Septum with predictability.

Nuth June 2010; We are pleased to share the press release of one of our Partners, Tryton Medical Inc.

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced results from the company’s TRYTON Side Branch Stent™ System presented during a Tryton-sponsored symposium in conjunction with the EuroPCR 2010 conference in Paris.

Robert-Jan Van Geuns, M.D., senior cardiologist at Erasmus Medical Center, Rotterdam, The Netherlands, presented data from the Rotterdam-Poznan Series, a two-center consecutive series that included 100 lesions from 96 patients followed for six months. Results from the Rotterdam-Poznan Series demonstrated a procedural success rate of 94 percent and a rate of target vessel revascularization of four percent at six months. The stented artery was a left main coronary artery in eight percent of the cases examined in the series.

Maciej Lesiak M.D., Ph.D., from the University Hospital in Poznan, Poland, presented acute data from the E-Tryton 150 study, a multicenter consecutive registry performed at eight leading European centers. The study enrolled 150 consecutive patients who received the Tryton Side Branch Stent. Results from the E-Tryton registry show a procedural success rate of 98.5 percent from treatment of bifurcation lesions with a wide distribution of angles and anatomic locations, including the left main coronary artery.

“Data presented at the Symposium contributes to the growing body of evidence demonstrating impressive acute procedural outcomes using the Tryton strategy,” said Martin B. Leon, M.D., of New York-Presbyterian Hospital/Columbia University Medical Center, who chaired the event. “The clinical data from Rotterdam-Poznan shows the durability of these results at six months which is consistent with the positive data from the First-In-Man study.”

Current approaches to treating bifurcation lesions have significant limitations, including higher rates of thrombosis – potentially fatal blood clots – and restenosis, the re-narrowing of the stented vessel following implantation. Tryton’s innovative solution to the persistent problem presented by bifurcation lesions is the Tryton Side Branch Stent System, which offers a dedicated strategy for bifurcation stenting across a broad range of anatomic angles and locations.

Left main disease, an accumulation of plaque that narrows the base of the coronary tree, until recently has been treated with bypass surgery. Recent studies have demonstrated that stents may provide physicians and patients with an important alternative.

Widespread adoption of stenting for left main disease has been hampered by the lack of a robust strategy for bifurcations lesions, which represent more than 75 percent of left main lesions. A Tryton strategy for left main disease has the potential to provide an important tool as stenting becomes established as a standard treatment for left main disease.

About the Tryton Side Branch Stent System
The Tryton 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. 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 commercially available in Austria, Belgium, Denmark, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, and the United Kingdom. It has been used to treat more than 1,250 patients with bifurcation disease.

Nuth, June 2010: On January 25th, 2010 Medtronic Inc announced the aquisition of Invatec S.P.A.. On July 3rd, 2010 TOP Medical will transfer the Invatec Benelux activities to Medtronic.

TOP Medical has been Invatec's exclusive Benelux Distributor for more then 7 years. We are very pleased that we have been able to contribute to Invatec's growth during this period. We will transfer all activities in close cooperation with Medtronic in order to guarantee an optimal service towards our customers and their patients.

TOP Medical will continue to identify new and innovative medical device technologies within the cardiovascular field and introduce them to the European, and more specifically the Benelux market.

For more information about our product portfolio please visit http://www.top-medical.com/products.html.

Nuth, May 2010: We are pleased to share a press release of one of our partners Cameron Health Inc.

Cameron Health, Inc. announced the publication of study results online in the New England Journal of Medicine (NEJM) highlighting the development and potential benefits of the company’s S-ICD® System, the first minimally invasive, subcutaneous implantable cardioverter defibrillator (ICD), for the treatment of sudden cardiac arrest (SCA). In the studies, the S-ICD detected 100 percent of induced and spontaneous episodes of irregular heart rhythms. This publication represents nine years of development and clinical work with 17 medical centers in seven countries.

The S-ICD System is unique in that its implantation is entirely subcutaneous (under the skin), eliminating the need for lead placement in or on the heart and simplifying the surgery by eliminating the need for imaging equipment. Transvenous ICD’s require placement of at least one lead in or on the heart. Most frequently, these leads are threaded through a vein and placed inside the heart, allowing 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 ongoing presence 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.

“Transvenous implantable cardioverter defibrillators have proven to be an effective therapy for treating sudden cardiac arrest, a leading cause of death in the United States. As with any medical technology, however, there is room for improvement,” said Gust H. Bardy, M.D. of the Seattle Institute for Cardiac Research, lead author of the NEJM paper and co-founder of Cameron Health. “These studies suggest that the S-ICD System is a viable alternative that may overcome some of the problems associated with transvenous ICDs in certain patients. The findings suggest that physicians now have an important new option to consider when evaluating patients for defibrillator therapy, and one that may reduce the barriers to adoption of this life-saving therapy.”

The NEJM publication highlights four studies of the S-ICD System. Two short-term trials designed to identify a suitable device configuration and assess energy requirements were followed by two longer-term trials designed to assess the efficacy of the S-ICD System in detecting and treating ventricular fibrillation and ventricular tachyarrhythmias. The trials were conducted between September 2001 and November 2009. Results of the longer-term studies include 100 percent detection of induced arrhythmias and 98 percent conversion success for patients implanted with the S-ICD System. In addition, ventricular tachyarrhythmias were detected and treated in 100 percent of 12 spontaneous episodes.

“Cameron Health’s goal in developing the S-ICD System was to significantly improve upon current ICD therapy by reducing the complications associated with transvenous leads, as well as to simplify implantation, programming and follow-up,” said Kevin Hykes, President and Chief Executive Officer, Cameron Health, Inc. “The publication of these data is a clear acknowledgement of the important pioneering contributions made by the clinical investigators. We believe that the S-ICD System has the capability to significantly lower adoption barriers, increase patient acceptance and ultimately save more lives.”

Clinical Trial Design

In the first of the short-term trials, four subcutaneous ICD configurations were evaluated in 78 patients who were candidates for ICD implantation. In the second of the short-term trials, the optimal configuration was then tested in 49 additional patients to determine the subcutaneous defibrillation threshold in comparison to the standard transvenous ICD. The optimal device configuration was as effective as a transvenous ICD but required a significantly higher energy requirement (36.6+/-19.8 joules vs. 11.1+/-8.5 joules). Long-term implants were evaluated in a six-patient pilot study followed by a 55-patient single-arm trial. In the pilot study, a total of 18 episodes of ventricular fibrillation were induced, all of which were appropriately detected, and all sustained episodes of ventricular fibrillation were successfully converted. In the 55-patient single-arm trial, all episodes of sustained ventricular fibrillation were appropriately detected, and 98% of patients satisfied implant testing criteria.

The full NEJM manuscript can be found at the following link http://content.nejm.org/cgi/content/full/NEJMoa0909545 .

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. The S-ICD System is capable of delivering 80 joules of energy. While most functions are automatic, adjustments and data retrieval can be easily achieved using the Q-TECH programmer, which is capable of wireless communication with the SQ-RX Pulse Generator. The S-ICD System received CE approval in 2009 and is commercially available in Europe.

The first U.S. patient was enrolled on March 3, 2010, in Cameron Health’s FDA pivotal trial (IDE number G090013). The trial, which is being conducted under an investigational device exemption (IDE), is a prospective, multicenter, single-arm design involving up to 330 subjects at up to 35 sites in the U.S., Europe and New Zealand. More information about Cameron Health’s IDE study can be found at http://www.clinicaltrials.gov (trial number NCT01064076), www.cameronhealth.com, or by contacting 1-800-877-3411 in the U.S. or +31 26 3550260 in Europe.

Nuth, May 2010: TOP Medical signs distribution agreement with Baylis Medical. 

Baylis Medical is committed to the development and commercialization of the new NRG RF Transseptal Needle to cross the Septum with predictability.

Please find a brochure attached!

Nuth, March 2010; We are pleased to post a press release of Cameron Health Inc. TOP Medical has the exclusive rights to promote and distribute the S-ICD in The Netherlands, Belgium and Luxembourg.

Cameron Health, Inc. today announced the commencement of the company's pivotal clinical trial to gain U.S. approval of its 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 S-ICD 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 are positioned using anatomical landmarks. The S-ICD System received CE approval in 2009 and is commercially available in Europe.

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 long term implantation of these transvenous leads within the patient’s heart are associated with a significant proportion of the complications related to this 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.

Cameron Health’s trial is a prospective, multicenter, single-arm design approved by the FDA under an investigational device exemption (IDE). The company plans to enroll up to 330 subjects at up to 35 sites globally. The study has primary clinical endpoints of arrhythmia conversion efficacy and complication free rate at 6 months for patients at risk of SCA.

Jay Warren, President and CEO of Cameron Health, Inc. explains, “Our goals are to reduce or eliminate the risks that attend transvenous implants, to refine the state of the art in rhythm discrimination and to simplify implant, programming and follow up for the physician. In essence, our S-ICD System is designed to provide patients with a safe, efficacious and minimally invasive alternative to conventional ICD’s.”

The IDE trial will involve patients at centers in the U.S., Europe and New Zealand. The first IDE implants were performed in New Zealand by Dr. Margaret Hood at Auckland City Hospital and by Dr. Ian Crozier at Christchurch Hospital. Initial implants in the U.S. were performed by Dr. Martin Burke, Director of the Heart Rhythm Center at the University of Chicago.

Commenting on the first patient to receive the S-ICD System in the U.S., Dr. Burke said, “Given the simplicity of the implantation I can see the potential to reduce the surgical and long term complications inherent in transvenous ICD systems.” The first U.S. patient to receive Cameron Health’s S-ICD System was Brooke Bergeron, who at 38 years old, suffered a heart attack during the birth of her fourth child. Her doctors recommended an implantable defibrillator due to heart damage that put her at risk for SCA. Brooke remarked, “I chose this novel technology because I just like the idea of not having any leads in or on my heart.”

Nuth, January 2010: TOP Medical is pleased to post a press release of its partner Concentric Medical.

CONCENTRIC MEDICAL ANNOUNCES FIRST PATIENTS TREATED WITH TREVO™ SYSTEM IN ACUTE ISCHEMIC STROKE
MOUNTAIN VIEW, CA, Jan 12, 2010 Concentric Medical, Inc., the global leader in acute ischemic stroke intervention, today announced that the first cases have been performed using its Trevo™ System in Europe. The Trevo System is an innovative, high performing, easy-to-use thrombus retrieval system. The main component of the Trevo System is a stentriever™, a new generation of retrieval devices which removes clots that cause stroke.
A number of renowned interventionalists have used the Trevo System for their patients in the last few weeks at leading European stroke centers. Professor Tommy Andersson MD PhD, Head of Neurointervention at Karolinska University Hospital, Stockholm, Sweden, completed one of the first cases and said, “The new Trevo System was remarkably effective. The Trevo was also very easy to use – this is key in being able to rapidly restore blood flow for patients suffering an acute ischemic stroke. I believe the Trevo System may represent a great advance in the treatment of this potentially devastating condition.”
Concentric Medical is the pioneer in developing devices for ischemic stroke intervention. Since 2004, Concentric Medical’s devices have been used in thousands of stroke patients worldwide. This experience has been incorporated into the design of the Trevo System to make thrombus removal an easier, faster and more predictable procedure.
Maria Sainz, President and CEO of Concentric Medical, said, “The Trevo System represents a very exciting opportunity for Concentric, one that has the potential to greatly expand the treatment of stroke. As a leader in stroke intervention, we are committed to bringing innovative tools to clinicians. We are also committed to offering the broadest range of interventional devices and systems to treat patients effectively.”
Concentric Medical currently markets the Merci Retriever®, which is the market leading solution for ischemic stroke intervention. In addition, Concentric’s DAC™ catheters are often used in the setting of ischemic stroke and other neurointerventional procedures. Together, the Trevo System, the Merci Retriever and the DAC family of catheters represent an unparalleled array of choices for physicians involved in the treatment of ischemic stroke.

Nuth, September 2009: TOP Medical signs distribution agreement with MicroVention

MicroVention is committed to the development and commercialization of new catheter-based technologies for the endovascular treatment of cerebral and peripheral vascular diseases.

The MicroPlex Coil System and the HydroCoilEmbolization System are both designed for endovascular placement in a cerebral aneurysm to occlude the aneurysmal sac, thereby stabilizing and isolating the aneurysm from the neurovasculature. Specific benefits of these MicroVention technologies include:

-- Ability to treat wide neck aneurysms.
-- Improved healing at the aneurysm neck.
-- More complete filling of the aneurysm.
-- Rapid thrombosis of the aneurysm.
-- Minimal migration.
-- Durable, long-term results.
-- Safety and handling characteristics equivalent or superior to other existing products.

The HydroCoil (HES) and HydroSoft embolic coils combine a proprietary hydrogel polymer with a platinum helical coil. Once inserted, the hydrogel expands to provide additional filling and finishing of a vascular space. The MicroPlex Coil System (MCS) consists of a uniquely designed embolization device to include a three-dimensional framing coil, helical filling coils and the HyperSoft finishing coil for use in all types of aneurysm morphologies. The V-Trak Delivery System comprised of the Delivery Pusher and V-Grip Detachment Controller provides a more simplified operation and delivery for all MicroVention embolization coils.

Nuth, October 2009: We are pleased to share the press release of the Antonius Hospital in Nieuwegein with regards to an Implantation of the Subcutaneous ICD from Cameron Health. TOP Medical has the exlusive distribution rights for sale of the S-ICD in the Benelux.

Demonstratie Implantatie onderhuidse of subcutane ICD

Woensdagochtend 14 oktober 2009 heeft in het St-Antonius Ziekenhuis onder leiding van dr. L. Boersma en in aanwezigheid van de pers een onderhuidse implantatie plaatsgevonden van een geheel nieuwe ICD, de zogenaamde subcutane of S-ICD. Dr. Lucas Boersma (St.Antonius Ziekenhuis Nieuwegein) heeft samen met Prof. Jordaens (Erasmus MC Rotterdam), Prof. Wilde (AMCU Amsterdam), en Prof. Van Gelder (UMCG Groningen) meegewerkt aan de ontwikkeling van dit volledig onderhuidse ICD systeem.

Bij traditionele ICD's moet er minstens één draad via de bloedvaten in het hart geplaatst worden. Deze draad geeft een signaal aan de ICD, zodra het hart een levensbedreigende ritmestoornis heeft. Aan deze huidige techniek is een aantal nadelen verbonden. Er is kans op infecties en er bestaat kans op draadbreuk of storingen. Een studie uit 2007 laat zien dat 15% van deze draden binnen 5 jaar een defect vertoont waarna een nieuwe chirurgische ingreep moet plaatsvinden. Ongeveer 17 mensen overlijden per jaar aan de complicaties bij een dergelijke draadbreuk of storing. Daarnaast wordt de huidige ICD ingebracht onder het sleutelbeen van de linkerschouder, wat bij het gebruik van de autogordel onprettig kan zijn.

Bij de nieuwe S-ICD-techniek wordt een elektrode vlak onder de huid links naast het borstbeen aangebracht en de ICD zelf onder de linkeroksel. Er zijn dus geen draden in het hart. Risico's als gevolg van problemen met de draad in de bloedvaten zijn met deze nieuwe techniek voorbij. Daarnaast is er geen röntgenstraling meer nodig voor de plaatsing. Het S-ICD-Systeem is ook ontworpen om het plaatsen en verwijderen gemakkelijker te maken en verkort tegelijkertijd de duur van de ingreep.

Een 4-minuten filmpje van de implantatie in Nieuwegein is te zien op RTV Utrecht, http://www.rtvutrecht.nl/nieuws/219572.

Nuth, April 2009: TOP Medical is pleased to announce that it signed an exclusive distribution agreement with Asahi Intecc for the distribution of the Corsair Microcatheter and the Sheatless Eaucath PTCA Guiding Catheter in The Netherlands, Belgium and Luxembourg.

The Corsair Microcatheter is developed as a septal channel dilator, to ease retrograde approaches for CTO-PCI. This is a unique device that can be used both as a microcatheter and as a support catheter.

The Sheathless Eaucath PTCA Guiding Catheter has been developed for less-invasive treatment and expand the usage of trans-radial approach.