First Patient Enrolled in Tryton Post Approval Study
The only FDA approved device to treat coronary bifurcations
Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced that the first patient has been enrolled in the post approval study to evaluate the Tryton Side Branch Stent System™ for the treatment of coronary artery disease.
The first case was performed by R. Lee Jobe, M.D., a partner of Joel Schneider, M.D., principal investigator of the study, at North Carolina Heart and Vascular, part of UNC REX Healthcare in Raleigh, N.C.
“The Tryton stent has become the preferred strategy for predictably treating my patients with coronary bifurcation lesions,” Dr. Schneider said. “This Post Approval Study is anticipated to confirm the excellent procedural and long term clinical outcomes we obtained in the Tryton Pivotal Study.”
“Greater than 20% of all percutaneous coronary interventions (PCI’s) involve a bifurcation for which Tryton is the only FDA approved device,” said Carl St. Bernard, president and CEO of Tryton Medical. “The enrollment of the first patient in the study is yet another milestone for Tryton, confirming the company’s commitment to education and understanding of the treatment of bifurcation disease in complex PCI.”
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.
About Tryton Side Branch Stent
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. The Tryton Side Branch Stent has now been used to treat more than 12,000 patients worldwide. It is commercially available in multiple countries within Europe, the Middle East and Africa, and is approved for use in the U.S.
Tryton Medical, Inc.
Judy Gonzalez, 919-226-1491
Source: Business Wire