Tryton Medical's Side Branch Short Stent Receives CE Mark Approval

May 16, 2013—Tryton Medical, Inc. (Durham, NC) announced that the company received CE Mark approval for the Tryton side branch short stent. The device features a stent length of 15 mm, which is 3 mm shorter in the main branch zone than the standard Tryton side branch stent, broadening the treatment options in bifurcations in large vessels with a short main-branch landing zone. The company is launching the product immediately in CE Mark countries with an introduction at the EuroPCR 2013 conference on May 21–24 in Paris, France.

Like the longer Tryton side branch stent system, the company's new short system incorporates the company's 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.

Joanna J. Wykrzykowska, MD, completed the first implant of the Tryton side branch short stent. Dr. Wykrzykowska, from the Academic Medical Center, University of Amsterdam in The Netherlands, commented in the company's press release, “The Tryton side branch short stent is an important advance in coronary stents. It gives me the control I need to treat patients who present with significant disease in a large, bifurcated vessel and whose anatomy in the main branch makes it challenging to deliver a longer size stent.”

Dr. Wykrzykowska continued, “The Tryton side branch short stent may be particularly helpful when treating disease in the left main artery. Left main coronary artery disease has historically been challenging to address interventionally, but this new stent provides confidence I can deliver it where it needs to go and ensure both the main branch and side branch openings receive optimum scaffolding and support.”

In the United States, the Tryton side branch stent is an investigational device. In November, Tryton announced that it completed enrollment in its randomized, controlled pivotal TRYTON clinical trial in the United States conducted under an investigational device exemption. The company anticipates that study outcomes will be presented at TCT 2013, to be held in San Francisco from October 28 to November 1.