October 28, 2016 – Tryton Medical Inc., a primary developer of stents to treat coronary bifurcation lesions, and Cardinal Health today announced that the companies have established a long-term strategic agreement for U.S. distribution of the Tryton Side Branch Stent, pending regulatory approval. Tryton submitted a pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Tryton Side Branch Stent in November 2015.
Bifurcation lesions are present in 20-30 percent of patients with coronary artery disease (CAD) who are treated with percutaneous coronary intervention (PCI). If approved, the Tryton Side Branch Stent would be the first stent specifically indicated for the treatment of bifurcation lesions in the United States.
Read the article "Tryton Completes Patient Enrollment in Pivotal FDA Side Branch Stent Trial."
“Bifurcation disease is one of the most significant unmet needs in interventional cardiology. The current practice of provisional stenting typically involves complex procedures with uncertain results,” said Shawn McCarthy, president and CEO of Tryton Medical. “Tryton is committed to providing physicians a predictable treatment strategy for bifurcation lesions based on an easy to use solution for any anatomical challenge. Pending our regulatory approval in the U.S., we are excited to collaborate with Cordis, Cardinal Health’s interventional vascular business, to achieve our goal of establishing a new standard of care with a definitive treatment for complex bifurcation disease.”
“In extensive clinical research, the Tryton Side Branch Stent has demonstrated an ability to provide predictability and durability when treating coronary bifurcation lesions with significant side branches,” said Dr. Martin Leon, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York-Presbyterian Hospital. “This uniquely engineered stent has the potential to disrupt standard strategies for treating complex bifurcation lesions.”
During the 28th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, Tryton will sponsor a clinical symposium entitled “Establishing the New Standard: Definitive Treatment for Complex Bifurcation Lesions.” The symposium featuring leading experts in the treatment of bifurcation will be held in Room 143B of the Walter E. Washington Convention Center in Washington, D.C. on Monday, Oct. 31 from 6:30-8 a.m. ET. Tryton is also exhibiting at booth 1343 at TCT 2016.
The Tryton Side Branch Stent System is built using proprietary Tri-Zone technology to offer a dedicated strategy for treating bifurcation lesions. Tryton’s cobalt chromium stent is deployed in the side branch artery using a standard single wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel. Tryton Side Branch Stent has now been used to treat more than 11,000 patients worldwide. The Tryton Side Branch Stent is commercially available in multiple countries within Europe, Middle East and Africa, is investigational in the U.S., and is not available in Japan.