FDA approves the Tryton Side Branch Stent

Coronary artery disease is one of the dominant reasons for deaths worldwide. This disease mostly leads to the growth of plaques at the location where an artery twigs from another that is called as bifurcation. Roughly, 20–30% patients undertaking percutaneous coronary interventions to release obstructed arteries are presented with a bifurcation lesion. At present, provisional stenting of the key branch is the standard of care, but in several surgeries the side branch remains unstented, leaving it susceptible to problems such as occlusion needing bailout stenting.

Recently, Tryton Medical, Inc. has earned a premarket approval from the Food and Drug Administration for its Tryton Side Branch Stent, which will be used for treating the coronary bifurcation lesions consisting of big side branches that are suitable for a ≥2.5mm stent. This device is the first committed bifurcation tool to obtain regulatory consent in the United States. The pioneering device is developed to be located in a side-branch artery along with an established drug-eluting stent to be situated into the main artery of the branch, thus treating the whole lesion at the bifurcation.

The Tryton Side Branch Stent is placed first, across the bifurcation and into the side branch. The configuration of the stent is intended to allow another release system to pass through its struts and then into the key branch, locating the bigger stent partly within and partly exterior to the side-branch stent. The 2 stents mutually offer entire treatment of the bifurcation, thus keeping it accessible without depending on potentially more complex endoprostheses.

Tryton Side Branch Stent’s safety profile was authenticated in a confirmatory trial. The study compared the patients who were treated with the test device to a performance objective dependent on the execution of the control arm. The expected primary endpoint of the confirmatory study was attained, that is, periprocedural myocardial infarction, which was observed to be its non-inferiority margin.

The Tryton Side Branch Stent is accessible in several device diameters, that is, in the range of 2.5–3.5mm in the side branch. The device is also well-suited with any traditional drug-eluting stent in the key vessel.

Poonam Bhosale-Gorade undertook the post of Team Lead–Content Writer at Medical Device News, following a 3-year stint as a writer and editor of books, reports, special publications. She holds a BE degree in Information technology from Pune University. Her hobbies include reading books, writing on Quora, trekking, playing badminton, etc. She is currently maintaining her blog Crazy Indian Stories (started recently).

She can be reached at: poonam@medicaldevicenews.net