TRYTON-LM clinical study enrolls first two patients

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced the enrollment of the first two patients in TRYTON-LM, a prospective, single-arm study evaluating the feasibility of the Tryton^® stent in conjunction with Abbott’s XIENCE PRIME™ Everolimus Eluting Coronary Stent System to treat stable patients with complex de novo bifurcation lesions involving the left main coronary artery.

The study will enroll 30 patients who will undergo a routine follow-up angiogram at six to eight months. Initial results from the first patients included in the registry will be presented at the annual EuroPCR conference taking place May 25 to 28, 2010 in Paris.

The first patients were enrolled by Pieter R. Stella, M.D., Ph.D., director of the Heart Catheterization Laboratories and Clinical Cardiovascular Research at the University Medical Centre in Utrecht, the Netherlands, who serves as principal investigator for the study.

“Left main disease presents unique challenges. Today, most left main blockages are left unstented or are addressed with bypass surgery. Tryton’s innovative system may offer the ability to definitively treat these lesions, setting the stage for stenting to become the new standard of care for the treatment of left main coronary artery disease, rather than bypass surgery,” said Dr. Stella.

“The Tryton Side Branch Stent has now been implanted in more than 500 European patients. This rapid adoption, in a limited number of centers, demonstrates significant repeat usage and is especially gratifying,” said J. Greg Davis, president and CEO of Tryton Medical. “We believe the Tryton-LM registry will help us understand how the Tryton Side Branch Stent may provide a solution for these difficult-to-treat bifurcation lesions.”

http://www.trytonmedical.com/