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Commenting on the approval Jeff Thiel, President and CEO said, "The treatment of coronary bifurcations represents a large market and is one of the most challenging procedures for interventional cardiologists.
director of Interventional Cardiology at Rabin Medical Center and Tel Aviv University, who also participated in the first two cases and also performed a case in his hospital, added, "Based on our first successful experiences, the Tryton stent seems to be an important new tool for interventionists as we take on cases involving complex bifurcations and the distal segment of the left main coronary artery.
The study, named "Bifurcation Optimized with the SLK-View(TM) Stent," or "BOSS," will utilize the SLK-View(TM) stent and delivery system to provide side branch access while treating coronary bifurcation lesions.
Vardi added, "I believe that our bifurcation stents and delivery systems represent a significant advance over other techniques and devices used to treat bifurcation lesions.
Young stated, "The SAB's main goal is to keep AST moving in the right direction and to solve important clinical problems in the bifurcation area.
First disconnectable and self-expanding platform for coronary artery bifurcation treatment receives European regulatory clearance
Food and Drug Administration has conditionally approved an Investigational Device Exemption ("IDE") for its AXXESS[TM] Biolimus A9[R] Eluting Bifurcation Stent System (AXXESS System), allowing the company to initiate a pivotal clinical trial (DIVERGE II) of the device in the United States.
The Open I study demonstrates that the Stentys bifurcated stent can be simply and safely implanted in patients with complex bifurcation lesions," concluded Stentys' CEO and co-founder, Gonzague Issenmann.
Of those, restenosis (re-occurrence of the blockage) occurs in 20-25 percent of bifurcations treated with drug-eluting stents (DES).
No doubt, he will play a critically important role in helping to establish that the Stentys bifurcation stent is as easy for cardiologists to use as conventional stents--but that our bifurcation stent is designed to provide superior treatment options by enabling full opening of the side branch.
A recent survey carried out on behalf of Cappella Medical and published in the May/June edition of Coronary Heart magazine, invited clinicians across Europe to share their views on the challenges and opportunities for improvement in the treatment of bifurcation lesion treatment (BLT).
Bifurcations throughout the vascular system are among the most common locations that atherosclerosis may form (2).