Technology | Stents Bifurcation | March 06, 2017

FDA Clears First Dedicated Coronary Bifurcation Stent

Tryton Side Branch Stent will be distributed by Cordis

tryton side branch stent, dedicated coronary side branch stent

The Tryton Side Branch 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.

tryton side branch stent, dedicated coronary side branch stent
tryton side branch stent, dedicated coronary side branch stent delivery balloon

The Tryton stent delivery balloon.

March 6, 2017 – The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) for the Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches. It is the first dedicated bifurcation device to receive regulatory approval in the United States and addresses an unmet need in coronary interventions.

Watch a VIDEO demonstration of the deployment for the Tryton Dedicated Bifurcation Stent.

Coronary artery disease (CAD), the leading cause of death in the United States in both men and women, often results in the buildup of plaque at a site where one artery branches from another, also known as a bifurcation. Approximately 20-30 percent of all patients undergoing percutaneous coronary interventions (PCI) to open blocked arteries have a bifurcation lesion. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.

 
“It is estimated that nearly a third of all patients treated with angioplasty each year have a bifurcation lesion, and the standard provisional treatment approach leads to side branch occlusion and bailout stenting far too often,” said Shawn McCarthy, president and CEO of Tryton Medical. “With this first-of-its-kind approval in the U.S., interventional cardiologists now have access to a stent that is specifically engineered to provide the complete lesion coverage and more predictable patient outcomes needed for the challenging anatomy of coronary bifurcation lesions.”
 
In a post hoc analysis of a randomized investigational device exemption (IDE) clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (appropriate for a ≥2.5 mm or larger stent) reduced the need for additional bailout stenting (0.7 vs. 5.6 percent, P = 0.02) and led to statistically significant lower side branch percent diameter stenosis at nine month follow up (30.4 vs. 40.6 percent, P = 0.004) when compared to provisional stenting. The post hoc analysis also showed comparable major adverse cardiovascular events (MACE) and myocardial infarction (MI) rates versus provisional stenting at three years.
 
The safety profile of the Tryton Side Branch Stent was validated in a confirmatory study that compared patients treated with the Tryton stent to a performance goal based on performance of the control arm from the randomized IDE clinical trial. The confirmatory study met its pre-specified primary endpoint, periprocedural myocardial infarction (PPMI), which was within its non-inferiority margin (Primary Endpoint: 10.5% + 95 percent C.I. vs. 17.9 percent, p=0.01).
 
“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,” said Aaron Kaplan, M.D., professor of medicine at Dartmouth Hitchcock Medical Center and chief medical officer of Tryton Medical. “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.”
 
Tryton has signed a strategic distribution agreement with Cardinal Health enabling Cordis, its interventional vascular business, to be the exclusive distributor of the Tryton Side Branch Stent in the U.S. “This strategic agreement is a significant step for Cordis to quickly get innovative technologies into the hands of our customers in the U.S. We are actively preparing to commercially launch this product with Tryton to ensure physicians will soon have a new treatment option in their cath labs to help deliver the best patient care available,” said David Wilson, president of Cordis.
 
The Tryton Side Branch Stent is available in multiple device diameters (2.5 to 3.5 mm in the side branch) and is compatible with any conventional drug eluting stent in the main vessel.
 
The stent is built using proprietary 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. The Tryton Side Branch Stent has now been used to treat more than 12,000 patients worldwide. It is commercially available in multiple countries within Europe, the Middle East and Africa, and is now approved for use in the U.S.

Links to more Information on  the Tryton Sidebranch Stent:

Tryton Side Branch Stent Meets Primary Endpoint in Pivotal Confirmatory Study

New Designs May Ease Bifurcation Stenting

New Directions for Stent Technology

 

For more information: www.trytonmedical.com

Related Content

American College of Cardiology Names Douglas Drachman Next Annual Scientific Session Vice Chair

Image courtesy of Massachusetts General Hospital

News | ACC | October 08, 2019
Douglas Drachman, M.D., FACC, has been selected as the next vice chair of the American College of Cardiology’s (ACC)...
SyncVision iFR Co-registration from Philips Healthcare maps pressure readings onto angiogram. Results from an international study presented at ACC 2019 indicates pressure readings obtained using iFR (instantaneous wave-free ratio, also referred to as instant wave-free ratio or instant flow reserve) in coronary arteries may localize stenoses that remain after interventions. FFR in the cath lab.

SyncVision iFR Co-registration from Philips Healthcare maps pressure readings onto angiogram. Results from an international study presented at ACC 2019 indicates pressure readings obtained using iFR (instantaneous wave-free ratio, also referred to as instant wave-free ratio or instant flow reserve) in coronary arteries may localize stenoses that remain after interventions.

Feature | ACC | March 27, 2019 | Greg Freiherr, Contributing Editor
The fingerprints of value-added medicine were all over products and works-in-progress on the exhibit floor of the a

The opening late-breaking trial at ACC 2019 is the Apple Heart Study, a large-scale, app-based study to identify atrial fibrillation using a smartwatch. Earlier, smaller trials showed this approach might be used in a population health application to proactively identify AFib patients earlier.

Feature | ACC | March 19, 2019
The American College of Cardiology (ACC) released a list of the late
A patient who received HeartMate III LVAD system at ACC.18. The HeartMate 3 was the topic of of the the key late-breaking trials at #ACC18

A patient who received the HeartMate III LVAD system showing off his external battery pack. He served as a patient ambassador in the Abbott booth at ACC.18. The HeartMate III, with its magnetic levitated pump, showed a big reduction in clotting over previous LVADs in a key late-breaking trial at this year's conference.

Feature | ACC | March 27, 2018 | Dave Fornell
There were several notable presentations of new data on cardiovascular technologies at the recent 2018 American Colle
Drug Stops Dangerous Bleeding in Patients Taking Factor Xa Inhibitors

Connolly 

News | ACC | March 22, 2018
March 22, 2018 — The experimental drug...
Videos | ACC | March 21, 2018
DAIC Editor Dave Fornell takes a tour of some of the most interesting new technologies on the expo floor at
ACC 2018 Late-Breaking Trials Announced
News | ACC | March 21, 2018
Here is a list of the American College of Cardiology (ACC) 2018 annual meeting late-breaking clinical trials presente
Inhaled Therapy Ineffective in Difficult-to-Treat Heart Failure at ACC 2018.

Image from presentation, "Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF: The INDIE-HFpEF Trial," Borlaug

News | ACC | March 20, 2018
March 20, 2018 — Four weeks of treatment with a novel inhaled medication failed to improve exercise capacity, daily a
More Deaths, Strokes Seen with Perioperative Beta Blocker One Year After Surgery

Image from presentation, "1-Year outcomes of perioperative beta-blockade in patients undergoing noncardiac surgery," Devereaux 

News | ACC | March 20, 2018
March 20, 2018 — During the 12 months after undergoing noncardiac surgery, patients with or at risk for heart disease
Trial for Gout Drug Meets Primary Endpoint, Raises Safety Concerns, image shows a CT scan showing gout in the knees.
News | ACC | March 20, 2018
March 20, 2018 — Febuxostat, a gout dr...
Overlay Init