Tryton Medical Inc. has garnered an FDA approval for its Side Branch Stent to treat coronary artery disease with lesions at major branches. This is the first approval for a dedicated bifurcation device in the U.S., according to the Durham, N.C.-based company. Cordis, part of Dublin, Ohio-based Cardinal Health Inc., has already signed a deal to be the sole U.S. distributor of the stent.

The Cordis deal dates back to last October, and the group is slated to launch the Side Branch Stent via its interventional vascular business later this month. Although the financial details are not disclosed, the pair are said to be in a long-term partnership.

WHAT'S NEXT FOR TRYTON?

Tryton is also planning to start a post-approval study of the stent this summer. The aim is to offer data to continue to convince U.S. health care providers that "new operators introduced to the technology can continue to generate reproducible results," Tryton President and CEO Shawn McCarthy told Medical Device Daily.

"We certainly will be focused on the U.S. market and demonstrating the use to physicians, and we are pursuing additional indications. We have an international business that we will continue to grow in the EU and expand into Asia," said McCarthy.

The Tryton stent gained CE mark in 2013, and the start up has been handling those marketing efforts on its own, with more than 12,000 patients having received the implant. The company plans to continue to expand in Europe on its own, but it's open to direct marketing and partnerships in Asian markets.

MAKING IT TO MARKET

It took more than eight years for Tryton to complete the U.S. regulatory path for the Side Branch Stent, starting with pre-IND meetings with the FDA. The company was initially founded in 2003 by Aaron Kaplan and H. Richard Davis. Kaplan continues to serve as Tryton CMO, while Davis is its COO.

Kaplan is a professor of medicine and the director of Dartmouth device development Symposia at Dartmouth Medical School and director of research at the Cardiac Catheterization Laboratories at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

Davis was formerly employed with Cordis, when it was part of Johnson & Johnson prior to its 2015 sale for almost $2 billion to Cardinal Health. In addition, he was also a co-founder of vascular device company Orbusneich.

The pair had a vision of developing stent systems specifically to treat bifurcation lesions. Workarounds such as provisional stenting, the current standard of care, typically leave the side branch not stented. That can lead to complications like occlusion that then require bailout stenting.

About 20 percent to 30 percent of all patients undergoing percutaneous coronary interventions (PCI) to open blocked arteries have a bifurcation lesion. That offers a sizeable potential market for Tryton's major partner, Cordis, to reach quickly with its vast existing sales force and clientele. Coronary artery disease is the leading cause of death in the U.S.

McCarthy said that reimbursement is already in place for the stent system. "Reimbursement is already established in the U.S., both codes and payment levels," said McCarthy. He noted that the system will be reimbursed on par with current alternatives in the U.S., but that in some European countries, such as Germany, it is being paid for at a premium to other options.

A NEW STANDARD FOR BIFURCATION

The pivotal testing for the Tryton Side Branch Stent involved more than 700 patients from up to 75 centers in North America, Europe and Israel. In a post-hoc analysis of the data in patients with large side branches – appropriate for use of a stent that's greater than or equal to 2.5 millimeter stent – versus provisional stenting, the Tryton stent was found to reduce the need for additional bailout stenting, lead to statistically significant lower side branch percent diameter stenosis at nine months, and to reduce major adverse cardiovascular events and myocardial infarction rates at three years.

"Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist," Kaplan said.

He added, "A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead."

The stent is deployed on the side branch artery using a standard single-wire, balloon-expandable stent delivery system. It has an open architecture, which allows for the integration of a conventional, drug-eluting stent for the main vessel. The idea is to enable complete lesion coverage.

To support its efforts, Tryton has raised more than $50 million in venture capital from investors including Rivervest Venture Partners, 3x5 Special Opportunity Fund and Canepa Healthcare.

The ultimate aim is for the Tryton stent, which will be driven entirely by Cordis in the U.S., to become the standard of care for PCI patients with a bifurcation lesion, a sizeable portion of stent patients.

"This is the new standard for treating complex bifurcations," said McCarthy. "The current standard, which is provisional stenting, is overused. Our goal is to establish a completely new standard for how physicians treat this, so this becomes the definitive treatment for complex bifurcations."