The FDA approved the Tryton Side Branch Stent on March 6 to treat coronary bifurcation lesions involving large side branches that are appropriate for a 2.5 mm or larger stent.
Tryton Medical, which manufactures the stent, announced the approval in a news release.
Tryton Medical also signed a deal with Cardinal Health that enables Cordis, Cardinal Health’s interventional vascular business, to exclusively distribute the Tryton Side Branch Stent in the U.S. Tryton Medical and Cardinal Health announced the agreement in October, pending regulatory approval of the stent. Tryton Medical had submitted a pre-market approval for the stent to the FDA in November 2015.
The Tryton Side Branch Stent is available in the Middle East, Europe and Africa and has been used in more than 12,000 patients worldwide. Physicians use a single wire balloon-expandable stent delivery system to deploy the Tryton cobalt chromium stent in the side branch artery and then place a conventional drug-eluting stent in the main vessel.
A post hoc analysis of a clinical trial found that patients with large side branches who received the Tryton Side Branch Stent had a reduction in the need for additional bailout stenting and statistically significant lower side branch percent diameter stenosis at nine months compared with provisional stenting. At three years, the rates of major adverse cardiovascular events and MI were similar between the groups.
Another study found that the Tryton Side Branch Stent was safe and met its pre-specified primary endpoint of periprocedural MI.
In July, Tryton Medical released results of a prospective study after a previous randomized trial did not meet its primary endpoint. Results of that study were published online in the Journal of the American College of Cardiology: Cardiovascular Interventions on July 4.
Tryton Medical, a privately held company founded in 2003, received an additional $4 million in equity financing in February and was looking for $4 million more, according to Mass Device. The Durham, North Carolina-based company disclosed the investment in an SEC filing, but it did not say how it would use the money.