Archive for September, 2008

Tryton launches Side Branch Stent System™ in Europe

Tryton Medical Inc., has launched its new Side Branch Stent System™ in Europe.
The novel stent system is designed to treat atherosclerotic lesions at the site of a bifurcation. The system will be available first in the Netherlands where TOP Medical has allied with Tryton for the distribution of the device. The Tryton Side Branch Stent System is an innovative technology that will solve the problems in the interventional treatment of patients suffering from complex coronary lesions, when used in combination with a conventional drug-eluting stent.

FDA approval to Covidien’s ANDA

The U.S. Food and Drug Administration (FDA) has approved Covidien’s Abbreviated New Drug Application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. This generic product from the company is pharmaceutically equivalent to Cardiolite®1, a myocardial perfusion imaging agent that is used to detect coronary artery disease. The kit from Covidien will now be available in the market of United States.

FDA expands indication for GORE VIABAHN Endoprosthesis

The US Food and Drug Administration (FDA) has broadened the approval to W. L. Gore & Associates for its GORE VIABAHN Endoprosthesis. The company can now market its product for use in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4.0 - 12.0 mm. Till now, this range had been limited to 4.0 - 7.5 mm. Gore is, now,  the only company with a stent-graft approved for both the SFA and iliac arteries.

MIV Therapeutics provides VESTASYNC I trial’s update

MIV Therapeutics, developer of advanced drug-delivery systems for cardiovascular stents and next-generation coatings, has released updates on the progress of the VESTASYNC I trial. MIV’s VESTAsync™, a polymer-free drug-eluting stent, going through an year long clinical has ensured prevention of major adverse cardiac events in patients who have not taken anti-platelet medication ( plavix). The company has accumulated nine-month intravascular ultrasound (IVUS) and Quantitative Coronary Angiography (QCA) for all the fifteen people who have been enrolled in the VESTASYNC I trial.

FDA clears Cardica’s PAS-Port for commercial launch

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Cardica, Inc. to market its PAS-Port(R) Proximal Anastomosis System for use in cardiac bypass surgery. The system creates a safe connection (anastomosis) between a vein graft and the aorta (the main artery in the human body) during coronary artery bypass grafting (CABG) procedures. The current method requires that the aorta be clamped which leads to the release of tiny blood clots or particles from it. These can reach the brain and cause stroke and other neurological complications.

FDA approves Edwards’ Perimount Magna mitral valve

The U.S. Food and Drug Administration (FDA) has approved the Carpentier-Edwards PERIMOUNT Magna mitral heart valve. This has allowed the Edwards Lifesciences Corporation, the world leader in the science of heart valves to launch the product in the United States. The valve is a pericardial tissue-based bioprosthetic device designed for the treatment of mitral valve disease. The PERIMOUNT Magna mitral valve provides patients and surgeons with an important option for mitral valve replacement with features like asymmetric shape, low profile and expansive sewing cuff.

Telmisartan helps in reducing cardiovascular risk

The TRANSCEND study authored by Dr Salim Yusuf, Hamilton Health Sciences and McMaster University, Hamilton (Ontario, Canada) concluded that the angiotensin-receptor blocker (ARB) telmisartan, when added to other reliable therapies,  proves to be of an additional advantage in treating patients who are unable to tolerate the standard treatment of angiotensin-converting enzyme (ACE) inhibitors. The researchers found in a trial that mean blood pressure was lower in the patients given a dose of telmisartan. Major adverse cardiovascular events such as death, heart attack or stroke were 13% less likely in telmisartan patients as against the placebo group.