First Patient Enrolled in Postapproval Study of Tryton Side Branch Stent
January 29, 2018—Tryton Medical, Inc. announced that the first patient has been enrolled in the postapproval study of the company's Tryton side branch stent system for the treatment of coronary artery disease. In March 2017, Tryton announced that the US Food and Drug Administration approved the device for treating large side branches (appropriate for a ≥ 2.5-mm stent). The Tryton side branch stent is available in multiple device diameters (2.5–3.5 mm in the side branch) and is compatible with any conventional drug-eluting stent in the main vessel.
The first case in the postapproval study was performed by R. Lee Jobe, MD, a partner of Joel Schneider, MD, who is the Principal Investigator of the study, at North Carolina Heart and Vascular, part of the University of North Carolina Rex Healthcare in Raleigh, North Carolina.
In the company's announcement, Dr. Schneider commented, "The Tryton stent has become the preferred strategy for predictably treating my patients with coronary bifurcation lesions. This postapproval study is anticipated to confirm the excellent procedural and long-term clinical outcomes we obtained in the TRYTON pivotal study."
Using the company's Tri-Zone technology, the Tryton side branch stent system provides a dedicated strategy for treating bifurcation lesions. The 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. It is commercially available in Europe, the Middle East, and Africa and is approved for use in the United States, advised Tryton Medical.