LeMaitre Vascular launches next generation stent graft delivery system.
LeMaitre Vascular has launch its TT Tortuous Tracker Delivery System, the next-generation introducer for LeMaitre Vascular’s EndoFit and UniFit Aortic Stent Graft product lines. The new delivery system will be available in the European Union and other select markets outside of the US from November 2007. The TT system is designed to simplify stent graft implants by requiring reduced deployment force, providing the physician with increased control over placement of the stent graft in the aorta. The TT system offers better flexibility and an improved coating to increase manoeuvrability through blood vessels and a three-part valve system to minimise blood loss during the medical procedure. The TT system also provides better visualisation during the procedure and a more ergonomic design. The TT system has already been used by physicians in over a dozen procedures designed to provide the company with pre-launch clinical feedback. “I was very pleased with the flexibility of the device and its ability to navigate tortuous vessels,” said Dr Thomas Larzon, Director of the EndoVascular Unit at Orebro University Hospital, Sweden. “It took much less physical effort to deploy the stent graft, which meant that I could more precisely position the stent graft where it would provide the best outcome for the patient.” “We are pleased to be able to offer a delivery system that we believe meets the high performance standards set by our stent graft products,” said George WLeMaitre, Chairman and CEO of LeMaitre Vascular. “We believe that the prior generation delivery system had discouraged adoption of our stent grafts. The TT system removes this impediment to growth.” The TT system will initially be available in a limited range of sizes as the company scales its production, with all sizes expected to become available by the end of 2008.
UNITE Update
At the recent VEITHSymposium in New York, Dr Rodney White, UCLA Medical Center, CA, presented an overview of the company’s UniFit Abdominal Stent Graft and the UNITE Clinical Trial. The UNITE pivotal study is evaluating the safety and effectiveness of the company’s UniFit Abdominal Stent Graft in the treatment of aorto, aorto-iliac, and/or iliac aneurysms. The Phase I study has enrolled 48 at five sites and the Phase II study is currently enrolling and has a planned recruitment target of 90 patients in up to 14 centres. The primary effectiveness endpoint of the study is based on aneurysm exclusion as evaluated through one- year follow-up. The UNITE study compares the safety and efficacy of the UniFit Abdominal Stent Graft against open surgical abdominal aorta repair. The UniFit Abdominal Stent Graft is a single-bodied aorto-uni-iliac stent graft used to treat an aortic aneurysm. The device’s encapsulated design minimises the extent to which its stents contact the blood stream or the vessel wall. This design also allows a wider range of stent graft sizes, including tapered and custom grafts, to fit a wider range of patient anatomies than many competing products.
Endovascular Skills Center
LeMaitre has also opened an Endovascular Skills Center at its international offices near Frankfurt, Germany. Courses at the Center offer both theoretical and practical hands-on elements, which are led by experienced endovascular clinicians. During the twoday course, attendees learn endovascular stent grafting essentials, trouble shooting, and both CT and traditional angiographic film reading and participate in valuable hands-on practice with life-like aortic pressure models supported by a fluoroscopic view screen.
