Search Results

Eighteen-Month Results of the DETOUR I Trial Presented for PQ Bypass' Detour System

November 6, 2018—Eighteen-month preliminary results from the DETOUR I trial were presented by Ehrin Armstrong, MD, at VIVA 18, the Vascular Interventional Advances, conference held November 5–8 in Las Vegas, Nevada.

MedAlliance’s SELUTION4BTK IDE Trial Begins Enrollment

June 8, 2022—MedAlliance announced that the first patient has been enrolled in the SELUTION4BTK trial.

Reva Medical’s MOTIV BTK Trial Meets Primary Efficacy Endpoint

April 29, 2026—Reva Medical, LLC announced primary endpoint results from the pivotal MOTIV BTK randomized clinical trial evaluating the safety and efficacy of the company’s Motiv sirolimus-eluting bioresorbable vascular scaffold in patients with infrapopliteal arterial disease.

MedAlliance Set to Begin SELUTION4BTK Randomized Trial of Its Selution SLR Sirolimus-Eluting Balloon

May 27, 2022—MedAlliance has announced receipt of FDA investigational device exemption (IDE) approval and its plans to begin enrollment in SELUTION4BTK, a randomized controlled trial evaluating the safety and efficacy of the company's Selution SLR sirolimus-eluting balloon in below-the-knee (BTK) peripheral artery disease.

Twelve-Month Outcomes Presented From Mercator MedSystems' TANGO Trial

November 6, 2019—VIVA Physicians announced the presentation of initial 12-month outcomes of the TANGO trial , a phase 2, dose-escalation, double-blinded trial comparing the delivery of temsirolimus versus saline in patients with severe claudication or critical limb ischemia, with the purpose of limiting neointimal hyperplastic tissue growth into the artery after endovascular below-the-knee (BTK) revascularization procedures.

Endologix TORUS 2 Study Completes Enrollment

November 23, 2021—Endologix LLC announced the completion of enrollment in the TORUS 2 IDE clinical study.

24-Month Outcomes Presented for PQ Bypass Detour Device

November 7, 2020—The Detour system (PQ Bypass) for percutaneous femoropopliteal bypass was evaluated for safety and effectiveness in the DETOUR 1 trial.

AngioDynamics Initiates AMBITION BTK Trial of Auryon System for CLI

January 30, 2025—AngioDynamics, Inc. announced the commencement of the AMBITION BTK multicenter randomized controlled trial (RCT), which will evaluate clinical outcomes of the company’s Auryon atherectomy system used in combination with standard balloon angioplasty versus standard balloon angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia (CLI) below the knee (BTK).

Akura’s Mechanical Thrombectomy Platform Used in FIH Study for VTE

May 10, 2023—Akura Medical, a privately held portfolio company of Shifamed LLC, announced it has initiated its first-in-human clinical study of the Akura mechanical thrombectomy platform.

Reva Medical Begins Enrollment in the MOTIV IDE Clinical Trial

September 27, 2022—Reva Medical, LLC, announced that enrollment in the MOTIV pivotal trial has been initiated at clinical centers in the United States and Europe.

AngioDynamics AMBITION BTK Trial Begins Enrollment

July 28, 2025—AngioDynamics, Inc. announced enrollment of the first patient in the AMBITION BTK study of the Auryon atherectomy system.

CMS Approves Coverage for PQ Bypass TORUS 2 IDE Trial

December 19, 2019—PQ Bypass Inc. announced it has received approval for coverage from the Centers for Medicare and Medicaid Services (CMS) for the TORUS 2 investigational device exemption (IDE) study.

Shockwave’s Disrupt BTK II Postmarket Study Commences Enrollment

November 22, 2021—Shockwave Medical, Inc., a developer of intravascular lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced the start of the Disrupt BTK II postmarket study to assess the safety, effectiveness, and optimal clinical use of the Shockwave Peripheral IVL System for the treatment of calcified peripheral lesions below the knee (BTK), including some of the most challenging patients with critical limb ischemia (CLI).