Medical Device Daily Senior
Tryton Medical (Durham, North Carolina) has received FDA conditional approval for an investigational device exemption application to start a pivotal trial to evaluate the Tryton Side Branch Stent System for the treatment of coronary artery disease.
Doug Ferguson, VP of regulatory affairs at Tryton, told Medical Device Daily that getting the technology into the U.S. regulatory process was his primary goal when he joined the company over two years ago.
“It's a significant milestone for us, something we're very excited about and we're raring to go,“ Ferguson said. “It's a process to get onto the market in the U.S., this is our first big step. Starting the clinical study will be great, it will give us a chance to show to the U.S. docs what we have and why we're excited about it.“
Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Tryton says current approaches to treating these lesions are time consuming and technically difficult. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation, according to the company.
The device is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. 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.
Getting conditional approval from FDA to start the trial is the culmination of “a whole lot of hard work for a number of years,“ Ferguson said. When he joined the company over two years ago it had just released the Tryton Side Branch Stent System in Europe. “It's great to see how far we've come. We have data in so many patients and it looks so promising so far.“
The randomized, controlled study will compare the use of the Tryton stent in the side branch in conjunction with a standard drug eluting stent in the main vessel vs. the use of angioplasty in the side branch with a standard drug eluting stent in the main vessel for the treatment of complex bifurcation disease. The primary endpoint of the study is target vessel failure at nine months. A secondary endpoint is percent diameter stenosis at nine months in the side branch vessel as assessed in an angiographic subgroup. About 374 patients will undergo angiographic follow up at nine months. The study will also include an IVUS substudy in 96 patients with IVUS follow up at nine months. The study will enroll 700 patients at up to 75 centers in North America and Europe.
Martin Leon, MD, professor of medicine and director of the Center for Interventional Vascular Therapy at Columbia University Medical Center (New York), and founder and chairman emeritus of the Cardiovascular Research Foundation (New York), will serve as principal investigator of the study.
“There is a significant need for alternative solutions for treating bifurcation disease, a persistent and challenging problem for interventional cardiologists that occurs frequently – in about two out of ten cases,“ Leon said. “Data from previous studies of the Tryton solution have been highly encouraging, and I look forward to results from this important trial.“
Earlier this year Tryton raised $20 million in 'D' round financing with the intention of using the proceeds to fund the U.S. pivotal trial. The company's Side Branch Stent System is approved for sale in Europe for the treatment of bifurcation lesions (Medical Device Daily, Sept. 15, 2010).
Privately held, Tryton is backed by Arnerich Massena & Associates, Spray Ventures, PTV Sciences, and RiverVest Ventures.
“The conditional approval of the investigational device exemption for the Tryton stent is a significant milestone for our company,“ said J. Greg Davis, president/CEO of Tryton. “We have seen substantial interest and adoption of the Tryton solution in Europe thus far and are excited to take the first step to bring this innovative treatment to patients and physicians in the United States.“
Tryton has been on a roll the last three months. In addition to the money it raised in September, the company reported in October that it had enrolled the first patient in its E-Tryton Italy study, a registry evaluation of its Side Branch Stent System (MDD, Oct. 13, 2010). That news came just a few weeks after releasing positive results from pre-existing registries (MDD, Oct. 1, 2010).
Results from 253 patients in the E-Tryton registry showed low rates of target lesion revascularization (TLR) and side branch failure (3.6% and 1.2%, respectively), with no incidences of stent thromboses. In an October interview with MDD, Aaron Kaplan, MD, a co-founder of the company, said the results are “remarkable and show a very low complication rate and a very high success rate.“
In addition, nine-month angiographic and IVUS follow-up results from the IUVANT study demonstrated a 3.2% rate of TLR, and no stent thromboses.
Ferguson said getting this conditional approval for a pivotal study in the U.S. is right on target with where Tryton had expected to be at this point.
“For me personally,“ Ferguson said, noting his role with the company as VP of regulatory affairs, “This is a significant step for us to head in this direction in the United States. It's great to see us getting here.“
Amanda Pedersen, 309-351-7774;