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First U.S. Case Done with Tryton's Side Branch Stent
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Tryton Medical Inc.

Tryton Side Branch Stent
Tryton Side Branch Stent
March 21, 2017 -- Earlier this month, the FDA approved Tryton Medical's Side Branch Stent and today, at New York-Presbyterian Hospital/Columbia University Medical Center in New York, the first case was performed by two of the leading interventional cardiologists in the U.S., Dr. Martin Leon and Dr. Ajay Kirtane.

Coronary blockages at the bifurcation of the left anterior descending artery and the diagonal branch (LAD/LADD) are not uncommon: about a quarter of all angioplasty procedures involve this area. And stenting the bifurcation has been challenging, because placing a stent in the main branch can often compromise the flow in the side branch. There have been many papers and presentations made over the years regarding techniques for treating this anatomic situation, but Tryton's device is the first to address this specific situation.

Tryton's unique device allows a stent to be placed in the side branch, preserving flow, and then a standard drug-eluting stent to be implanted in the main artery. The two stents are seamlessly integrated, resulting in an optimal result.

The Tryton side branch stent will be distributed through Cordis, previously part of Johnson & Johnson and now part of Cardinal Health. Cordis, the company that marketed the one of the first stents, the Palmaz-Schatz, and subsequently the first drug-eluting stent, Cypher, exited the coronary stent business in 2011. The Tryton represents their re-entry.

This morning's press release from Tryton follows:

Tryton Medical Announces First U.S. Commercial Case with Tryton Side Branch Stent
Patient with coronary bifurcation lesion involving large side branch treated with first dedicated bifurcation stent to receive regulatory approval in the U.S.

March 21, 2017 -- Durham, North Carolina -- Tryton Medical, Inc., the leading developer of stents designed to treat coronary bifurcation lesions, today announced that the first U.S. commercial case using the Tryton Side Branch Stent to treat a coronary bifurcation lesion involving a large side branch (appropriate for a >2.5mm stent) was completed at New York-Presbyterian Hospital/Columbia University Medical Center in New York City. The procedure was performed by Martin Leon, MD, director of the Center for Interventional Vascular Therapy, and Ajay Kirtane, MD, SM, director of the Cardiac Catheterization Laboratory.

Dr. Ajay Kirtane
Dr. Ajay Kirtane

Approximately 20-30% of all patients undergoing percutaneous coronary interventions (PCI) to open blocked arteries have a bifurcation lesion. The Tryton Side Branch Stent recently became the first dedicated bifurcation device to receive regulatory approval in the U.S. Tryton has signed a strategic distribution agreement with Cardinal Health enabling Cordis, its interventional vascular business, to be the exclusive distributor of the Tryton Side Branch Stent in the U.S.

Dr. Martin Leon
Dr. Martin Leon

“Dr. Leon and the cath lab team at Columbia University Medical Center played an integral role investigating the Tryton Side Branch Stent through extensive clinical research leading to the recent FDA approval,” said Shawn McCarthy, president and CEO of Tryton Medical. “We are honored to have the team at Columbia perform the first U.S. commercial case and appreciate their guidance during the Tryton Clinical Trials and leadership they provide for the interventional community around the world. Tryton looks forward to working with Cordis to ensure interventional cardiologists in the U.S. have access to a dedicated bifurcation device.”

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.

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 the Geisel School of Medicine/Dartmouth-Hitchcock Medical Center, to develop stents for the definitive treatment of bifurcation lesions. For more information please visit and follow the company on Twitter at @TrytonMedical1.

Reported by Burt Cohen, March 21, 2017