Cook Medical recently announced that the first US patients involved in a Phase II clinical trial of the Zilver PTX Stent were treated at Tri-City Medical Center in Oceanside, CA. The Trial is taking place at 28 US locations and represents the first medical device trial conducted simultaneously in the US and Japan. Based on clinical data results collected, Cook Medical will be seeking regulatory approval in both markets. This stent is intended to treat peripheral arterial disease (PAD), which affects more than 10 million Americans each year. Stent implementation is an exciting option because patients can often avoid surgery and get back on their feet much more quickly after having a stent implanted. It will be interesting to see if the same drug-eluting technology found in cardiovascular stents can be used to treat blockages in arteries outside of the heart – or if any of the long-term clotting concerns will be raised with these products as they have with the cardiovascular stents.
Similarly, ev3 Inc. also announced they have received conditional IDE approval from the FDA to study the Protégé EverFlexTM Self-Expanding Stent System for the treatment of PAD. This trial (DURABILITY II) represents the first trial in the treatment of PAD to explore single-stent treatment of lesions as long as 16 centimeters and be fracture resistant at five years. The EverFlex stent represents a bare nitinol stent option. The stent has been available in the US since February 2006 for the treatment of malignant neoplasms in the biliary tree. This study will determine if the product usage can be expanded to include treatment of PAD.
Treatment options for PAD
Source: Allina Hospitals and Clinics
Original Article: http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20070716005199&newsLang=en
Well, all I know is the stent has been available in the US since February 2006 for the treatment of malignant neoplasms in the biliary tree.
Sam
Posted by: cpap | April 28, 2010 at 03:29 AM