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, 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.