Growing Body of Data Positions Tryton Stent As Potential Alternative to Provisional Stenting

Durham, N.C. – Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced the latest data from a pooled analysis of 905 patients treated with the Tryton Side Branch Stent.™ Results were presented last week in Miami, Fla., by Joanna J. Wykrzykowska, M.D., Ph.D., of the University of Amsterdam as part of a standing-room-only Transcatheter Cardiovascular Therapeutics (TCT) 2012 satellite symposium co-chaired by Professors Martin B. Leon, M.D., of Columbia University Medical Center in New York and Patrick W. Serruys, M.D., Ph.D., of Erasmus University, Rotterdam, Netherlands.

In addition, the company announced live satellite transmissions of two successful clinical cases using the Tryton stent to audiences of over 1,000 interventional cardiologists attending the conference.

Data from the analysis of eight registry studies showed that in the real-world setting, the rate of target lesion revascularization (TLR) for bifurcation lesions treated with the Tryton stent was 4 percent at one year, with a stent thrombosis rate of 0.5 percent.

“This analysis shows that the use of the Tryton stent is associated with procedural and mid-term clinical results that compare favorably with previous smaller studies of the device and with large studies of other techniques.  The low stent thrombosis rate is particularly encouraging, given the association of bifurcation lesions with a historically higher risk for stent thrombosis,” said Dr. Wykrzykowska.  “I believe that the growing and consistently positive body of clinical data for the Tryton stent does in fact position the device as an attractive alternative to traditional provisional stenting techniques.”

These results and other findings from various registries were confirmed in SAFE-Try, the largest prospective multicenter trial to date of the Tryton stent, which evaluated safety and efficacy in 251 patients. Data, which were presented at TCT by Giuseppe Tarantini of the University of Padua in Padua, Italy, showed a TLR of 4.4 percent and zero stent thrombosis at nine months.

During the satellite symposium, Professors Leon and Serruys provided an overview and update on the Tryton Pivotal IDE Study, the first and only randomized controlled U.S. IDE pivotal clinical trial evaluating a dedicated bifurcation stent. The 704-patient study compares a Tryton stent in the side branch vs. the use of balloon angioplasty in the side branch, with both arms of the trial utilizing a standard drug eluting stent in the main vessel.

“It’s clear that bifurcation disease represents a significant unmet clinical need, evidenced by the overflowing attendance at symposia throughout the week,” said Shawn P. McCarthy, president and CEO of Tryton Medical.  “Momentum for Tryton Medical continues to build, with more than 6,000 patients now treated with our stent system around the world and completion of enrollment in our U.S. pivotal IDE study expected in the coming days.  We look forward to submitting results of the trial to FDA for approval and to introducing our technology in the United States.”

The Tryton stent is commercially available throughout Europe, Russia and the Middle East.  Clinical data presented on more than 1,000 patients treated with the Tryton stent has demonstrated consistent target lesion revascularization rates of less than four percent and low thrombosis rates at six-month follow up and beyond.

Source: Tryton Medical, Inc.