Global Bifurcation Leader Tryton Medical Announces Events at TCT 2013

SAN FRANCISCO–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to treat bifurcation lesions, today announced activities highlighting the latest data and experience with the Tryton Side Branch Stent at the 25^th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. TCT takes place October 28-November 1, 2013 at The Moscone Center in San Francisco, California. The company will exhibit in booth 1907.

On Wednesday, October 30 the first results from the Tryton Side Branch Stent Pivotal IDE trial will be presented by Dr. Martin B. Leon during the morning Late Breaking Clinical Trial session. The presentation will take place in Main Arena II at 10:20 am PDT. Dr. Leon serves as principal investigator of the study.

The Tryton Pivotal IDE trial is an international, randomized study that compares a Tryton Stent in the side branch to conventional provisional stenting (balloon angioplasty) in the side branch, with both study groups receiving a standard drug eluting stent (DES) in the main vessel. The study, which is the first randomized FDA IDE pivotal clinical trial to evaluate a dedicated bifurcation stent, enrolled 704 patients at 67 centers in North America and 11 countries throughout Europe and Israel. It is the largest coronary bifurcation study ever conducted and the first study to employ core lab angiographic (3D and planar) and IVUS analysis.

In advance of the unblinding of the results from this first-in-class trial, Dr. Leon will present on Monday, October 28 at Left Main and Bifurcation Stenting: An Advanced Operator’s Workshop during Session VIII on Dedicated Bifurcation Stents. He will present on the topic of “The Case for Dedicated Bifurcation Stents; Device and Regulatory Landscape; and Anticipation of the Pivotal Tryton Results”. The session also explores dedicated bifurcation stents and left main disease, the debate over the utility of dedicated bifurcation stents, an audience vote and expert discussion. This session will be held from 5:26-6:10 pm PDT in Moscone West, 3^rd Floor, Room 3006.

On Thursday, October 31, Dr. Leon and Patrick W. Serruys, M.D., Ph.D. will chair a symposium regarding the Tryton Side Branch Stent. At the symposium clinicians will further examine the clinical and angiographic outcomes from the IDE trial, review the historic body of clinical evidence, present real-world Tryton Stent cases and provide perspectives on treating a broad spectrum of bifurcation anatomies. Martin B. Leon, M.D., Philippe Généreux, M.D., Indulis Kumsars, M.D., Pieter R. Stella, M.D., Ph.D. and Robert-Jans van Geuns, M.D., Ph.D. are scheduled to present at the symposium. The symposium will take place from 7-8 a.m. PDT in Room 121.

Additionally, on Tuesday, October 29 the Tryton Stent will be featured in the Challenging Cases forum and in Poster Abstract sessions:

• In the Challenging Case: Coronary session from 3:30-5:30 pm PDT in Moscone West the following data will be presented:
  • Robin Kraak, M.D., will host: “Treatment of complex coronary bifurcation lesion; ABSORB BVS in combination with Tryton short dedicated bifurcation stent” and “Treatment of complex coronary bifurcation lesion in a patient with acute ST elevation myocardial infarction; ABSORB BVS in combination with Tryton dedicated bifurcation stent”.
  • Balazs Berta, M.D., will host “Trifurcational occlusion treated by dedicated bifurcation stent in ST-elevation myocardial infarction from transradial approach”.
• In the Bifurcations and Left Main Interventions session from 3:30-5:30 pm PDT in Moscone West, 1^st Floor, Maik Grundeken, M.D., will host “First Report on Long-term Clinical Results After Treatment of Coronary Bifurcation Lesions With the Tryton Dedicated Bifurcation Stent”.

More information about TCT 2013 can be found at http://www.tctconference.com/.

About Coronary Bifurcation Disease

Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating these lesions are time consuming and technically difficult. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation. In patients undergoing PCI-stenting, approximately one-third have a bifurcation lesion. Left main disease, an accumulation of plaque that narrows the base of the coronary tree, is a persistent challenge in interventional cardiology, as more than 75 percent of left main lesions are bifurcation lesions.

About the Tryton Side Branch Stent System

The Tryton Side Branch Stent System is built for bifurcation 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.

About Tryton Medical, Inc.

Tryton Medical, Inc., located in Durham, N.C., is the leading developer of novel stent systems for the treatment of bifurcation lesions. The company was founded in 2003 by Aaron V. Kaplan, M.D. (professor of medicine at Dartmouth Medical School/Dartmouth- Hitchcock Medical Center) and Dan Cole, General Partner at Spray Ventures. Privately held, Tryton is backed by PTV Sciences, RiverVest Venture Partners, Spray Venture Partners, and the 3×5 Special Opportunity Fund. For more information please visit trytonmedical.com/us and follow the company on Twitter at @TrytonMedical1.