News | Stents Bifurcation | October 14, 2015

Tryton Side Branch Stent Meets Primary Endpoint in Pivotal Confirmatory Study

Positive results presented at Transcatheter Cardiovascular Therapeutics symposium support planned PMA submission

Tryton Confirmatory Study, Side Branch Stent, TCT 2015, bifurcation lesions

Image courtesy of Tryton Medical

October 14, 2015 — Tryton Medical Inc. announced results from the pivotal Tryton Confirmatory Study confirming the acceptable acute safety profile of the Tryton Side Branch Stent for the treatment of coronary bifurcation lesions in vessels appropriate for a ≥2.5mm stent. Results were presented as part of the Featured Clinical Research session at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation (CRF) being held in San Francisco, California.

The Tryton Confirmatory Study (single-arm clinical trial, n=133) was designed to validate the acute safety profile of the Tryton Side Branch Stent shown in a post hoc analysis of the Tryton Randomized Clinical Trial (RCT, n=704). The post hoc analysis of the Tryton RCT showed the device reduced target vessel failure and improved side branch percent diameter stenosis when compared with provisional stenting in the intended treatment population (appropriate for a ≥2.5mm stent). The Tryton Confirmatory Study showed a periprocedural myocardial infarction (PPMI) rate (primary endpoint) meeting the pre-established performance goal, set based on the PPMI rate of the provisional control arm observed in the Tryton RCT.

Results from the post hoc analysis of the Tryton RCT and the data from the Tryton Confirmatory Study will be used to support Tryton’s Premarket Approval (PMA) application for Tryton Side Branch Stent to the U.S. Food and Drug Administration in the coming weeks.

“These findings provide strong clinical evidence demonstrating that the Tryton Side Branch Stent provides predictability and durability when treating coronary bifurcation lesions with significant side branches, while preserving main vessel results,” said principal investigator Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York-Presbyterian Hospital. “With an established safety profile, Tryton has the potential to disrupt standard strategies for treating complex bifurcation lesions.”

The Tryton Side Branch Stent System 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 device is commercially available in multiple countries within Europe, Middle East & Africa, is investigational in the United States and is not available in Japan.

For more information: www.trytonmedical.com

Related Content

Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology, which are transcatheter devices used to seal brain aneurysms. The company said there is a risk of the delivery system’s wire and tubes fracturing and breaking off when the system is being used to place, retrieve, or move the stent inside a patient.
News | Cath Lab | September 21, 2021
September 21, 2021 — Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Devi
Feature | Cath Lab | September 14, 2021 | By Aaron Detate and Lars Thording
In the electrophysiology (EP) lab, hundreds
An example of the Medis QCA angiography imaging derived fractional flow reserve (FFR) assessment. This technology removes the need for pressure wires and adenosine used in traditional FFR assessments of the coronary arteries.

An example of the Medis QCA angiography imaging derived fractional flow reserve (FFR) assessment. This technology removes the need for pressure wires and adenosine used in traditional FFR assessments of the coronary arteries.

News | Cath Lab | July 22, 2021
July 22, 2021 — Medis Medical Imaging is partnering with CORRIB Core Lab and Sinomed in randomized clinical trial of
ast End Medical announced it received U.S. Food and Drug Administration (FDA) clearance for the company's SafeCross Transseptal Radiofrequency (RF) Puncture and Steerable Balloon Introducer System. The 3-in-1 system, which includes a steerable introducer sheath with an ultra-visible positioning balloon and radiofrequency (RF) puncture dilator, aims to provide a predictable and safe solution for electrophysiology (EP) and structural heart interventions requiring left atrial access.
News | Cath Lab | July 14, 2021
July 13, 2021 — East End Medical announced it received U.S.
There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal function are being excluded from interventional procedures because they are automatically considered too high risk. However, some hospitals are also creating cardio-renal care teams so these patients can be cared for by a team of experts rather than interventional cardiologists going it alone. #SCAI21 #SCAI2021 Creating a card0-renal program.

There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal function are being excluded from interventional procedures because they are automatically considered too high risk. However, some hospitals are also creating cardio-renal care teams so these patients can be cared for by a team of experts rather than interventional cardiologists going it alone.

Feature | Cath Lab | May 14, 2021 | By Dave Fornell, Editor
There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal fun
Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has gained European CE marked. This first-of-its-kind imaging software merges optical coherence tomography (OCT) intravascular imaging with the power of artificial intelligence (AI) for enhanced visualization. The new Ultreon Software can automatically detect the severity of calcium-based blockages and measure vessel diameter to enhance the precision of physicians’ decision-making during coronary stenting proc

Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has gained European CE marked. This first-of-its-kind imaging software merges optical coherence tomography (OCT) intravascular imaging with the power of artificial intelligence (AI) for enhanced visualization. The new Ultreon Software can automatically detect the severity of calcium-based blockages and measure vessel diameter to enhance the precision of physicians’ decision-making during coronary stenting procedures.

News | Cath Lab | May 12, 2021
May 12, 2021 — Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has
SCAI 2021 late-breaking presentations included the data on the Medtronic Harmony transcatheter pulmonary valve, cutting radial access hemostasis time by 50 percent, improving cardiogenic shock survival to 71 percent, and data showing very high mortality in COVID patients who suffer a STEMI heart attack. #SCAI21 #SCAI2021

SCAI 2021 late-breaking presentations included the data on the Medtronic Harmony transcatheter pulmonary valve, cutting radial access hemostasis time by 50 percent, improving cardiogenic shock survival to 71 percent, and data showing very high mortality in COVID patients who suffer a STEMI.

Feature | Cath Lab | May 06, 2021 | By Dave Fornell, Editor
April 29, 2021 — Here is the list of late-breaking study presentations and links to articles about each of them from
Most Stable Ischemic Heart Disease Patients Did Not Meet ISCHEMIA Trial Enrollment Criteria, raising questions about its application in real-world practice. #SCAI2021 Getty Images

Getty Images

News | Cath Lab | May 03, 2021
May 3, 2021 – Results from a new study find a broad range of patients who typically undergo revascularization for sta
New study demonstrates depression, HIV, mental health, obesity, alcohol and drug abuse are risk factors on most common type of heart disease in young black patients. Photo by Dave Fornell
News | Cath Lab | April 29, 2021
April 29, 2021 – A retrospective analysis of risk factors for coronary artery disease (CAD) in young African American