News | Stents Peripheral | February 08, 2016

Stentys Launches Self-Expanding Below-The-Knee Drug-Eluting Stent

Device will launch first in Germany and Belgium following successful results of PES BTK-70 trial

Stentys, commercialization, BTK stent, below-the-knee arteries

February 8, 2016 — Stentys announced the first distribution agreements for its drug-eluting stent for treating below-the-knee (BTK) arteries in Germany and Belgium, making it the first self-expanding drug-eluting stent commercialized for this indication in Europe.

The Stentys stent obtained CE Marking for the BTK indication at the end of 2015 following the results achieved by the PES BTK-70 study, where it prevented amputation in 99 percent of the 70 patients treated for critical limb ischemia (CLI). The trial treated patients suffering from CLI of class 4 and 5 in the Rutherford scale with a Stentys paclitaxel-eluting stent from January 2012 to May 2013 in five hospitals. The primary endpoint was the 12-month primary patency rate defined as absence of restenosis (≥50 percent) or occlusion within the originally treated lesion based on angiography verified by Core Lab. At 12 months, the primary patency rate was 73 percent, freedom from target-lesion revascularization was 79 percent and freedom from amputation was 99 percent.

For more information: www.stentys.com

Related Content

The FDA-Cleared XO Score is different. XO Score technology allows users to convert basic angioplasty balloons in the hospital's existing inventory into sophisticated scoring, cutting, and infusion/delivery devices. 

The FDA-Cleared XO Score is different. XO Score technology allows users to convert basic angioplasty balloons in the hospital's existing inventory into sophisticated scoring, cutting, and infusion/delivery devices. 

News | Peripheral Artery Disease (PAD) | November 13, 2020
November 13, 2020 — The new U.S.
he 36-month results from Veryan Medical’s MIMICS-2 study for the BioMimics 3D femoropopliteal stent showed low rates of revascularization and compared very favorably to current standards of care.  The results were presented by Professor Thomas Zeller, M.D., University Heart Centre Freiburg, Bad Krozingen, Germany at the CX 2020 Live conference.   
News | Peripheral Artery Disease (PAD) | June 16, 2020
June 16, 2020 — The 36-month results from Veryan Medical’s MIMICS-2 study for the BioMimics 3D femoropopliteal stent
The VOYAGER PAD trial showed patients with symptomatic peripheral artery disease (PAD) who took the blood thinner rivaroxaban with aspirin after undergoing a procedure to treat blocked arteries in the leg had a 15 percent reduction in the risk of major adverse limb and cardiovascular events when compared with those receiving aspirin alone. #ACC20

The VOYAGER PAD trial showed patients with symptomatic peripheral artery disease (PAD) who took the blood thinner rivaroxaban with aspirin after undergoing a procedure to treat blocked arteries in the leg had a 15 percent reduction in the risk of major adverse limb and cardiovascular events when compared with those receiving aspirin alone.

News | Peripheral Artery Disease (PAD) | March 28, 2020
March 28, 2020 — People with symptomatic...
News | Peripheral Artery Disease (PAD) | November 14, 2019
November 7, 2019 — Ultrasoundplasty before angioplasty for below-the-knee lesions (BTK) lesions may improve clinical
News | Peripheral Artery Disease (PAD) | November 14, 2019
November 14, 2019 — There were positive results in the TANGO Trial is a phase 2, dose escalation, double-blinded tria
The LimFlow procedure permanently bypasses unreconstructable arteries and leverages healthier veins as a conduit to create new routes to perfuse tissue in the foot.  #VIVA #VIVA19 #VIVA2019

The LimFlow procedure permanently bypasses unreconstructable arteries and leverages healthier veins as a conduit to create new routes to perfuse tissue in the foot. 

News | Peripheral Artery Disease (PAD) | November 14, 2019
November 14, 2019 — Results were positive for the multicenter PROMISE I Trial represents the first human use in the U
Eluvia and Ranger PAD devices from Boston Scientific. #VIVA19 #VIVA2019 #VIVA
News | Peripheral Artery Disease (PAD) | November 06, 2019
November 6, 2019 – Boston Scientific announced positive data for two of its devices within the peripheral drug-elutin
FDA Panel Recommends Continued Use of Paclitaxel-coated Peripheral Devices
Feature | Peripheral Artery Disease (PAD) | August 28, 2019 | Jeff Zagoudis, Associate Editor
The U.S. Food and Drug Administration (FDA) released an updated MedWatch Alert this month on the safety of paclitaxel-...
New Report Says Concept Medical Positioned to Disrupt Peripheral Market
News | Peripheral Artery Disease (PAD) | August 27, 2019
Concept Medical was recently granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA)...