News | 09.21.20
AngioDynamics’ Auryon Atherectomy System Commercially Launched in the United States
September 21, 2020—AngioDynamics, Inc. announced the United States commercial launch of the Auryon atherectomy system for the treatment of peripheral artery disease (PAD), including critical limb ischemia (CLI) and in-stent restenosis (ISR).
News | 09.17.20
BIO4AMB Trial Evaluates Biotronik’s 4-F Devices in Treating Ambulatory PAD
September 17, 2020—Biotronik announced that new clinical data from the BIO4AMB trial demonstrate that 4-F–compatible devices are a valid, safe option for endovascular treatment of ambulatory lower extremity peripheral artery disease and show similar results to 6-F devices, with the added benefit of eliminating the need for a vascular closure device.
News | 09.11.20
FDA Clears Avinger’s Next-Gen Ocelaris CTO Crossing System, to Be Marketed as Tigereye
September 11, 2020—Avinger, Inc. announced that the company received FDA 510(k) clearance for its Ocelaris next-generation image-guided chronic total occlusion (CTO) crossing system for the treatment of patients with peripheral artery disease.
News | 09.03.20
Abbott Begins LIFE-BTK Trial to Evaluate Esprit BTK Drug-Eluting Resorbable Scaffold to Treat CLI
September 3, 2020—Abbott announced the start of the LIFE-BTK clinical trial to evaluate the safety and effectiveness of the company’s new Esprit below-the-knee (BTK) everolimus-eluting resorbable scaffold system.
News | 09.03.20
CardioVascular Coalition Urges Congress to Support Limb Loss Prevention and Block Proposed Medicare Cuts
September 3, 2020—CardioVascular Coalition (CVC) announced it is urging Congress to support policies to improve peripheral artery disease (PAD) screening, diagnoses, and treatment to reduce lower limb amputations in recognition of PAD Awareness Month.
News | 09.02.20
PQ Bypass's Detour Device Receives FDA Breakthrough Device Designation
September 2, 2020—PQ Bypass Inc, announced that it has received Breakthrough Device designation from the FDA for the company's Detour system, a fully percutaneous femoral-popliteal bypass device intended to treat extremely long, complex blockages in the superficial femoral artery (SFA).
News | 08.27.20
Enrollment Commences in FUTURE BTK Trial of Concept Medical’s MagicTouch Sirolimus-Coated Balloon
August 27, 2020—Concept Medical Inc. announced the enrollment of the first patient in the randomized controlled FUTURE BTK trial of the company’s MagicTouch sirolimus-coated balloon for percutaneous transluminal angioplasty (PTA) versus standard balloon angioplasty in the treatment of below-the-knee (BTK) artery disease in patients with critical limb ischemia (CLI).
News | 08.24.20
Analysis of German Insurance Claims Shows Improved Long-Term Outcomes With Paclitaxel-Coated Devices in BTK Revascularization
August 24, 2020—Christian-Alexander Behrendt, MD, announced the publication of a study on long-term outcomes with paclitaxel-coated devices used to treat chronic limb-threatening ischemia (CLTI) in below-the-knee (BTK) arteries.
News | 08.17.20
Postmarket PATHFINDER I Registry Commences for AngioDynamics’ Auryon Atherectomy System
August 17, 2020—AngioDynamics, Inc. announced the enrollment of the first patient in the postmarket PATHFINDER I registry, which is a pilot study designed to evaluate the safety and efficacy of the company’s Auryon atherectomy system in the real-world treatment of de novo, restenotic, and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD).
News | 08.07.20
iD3 Medical Commences SUPERSURG Study of Abbott’s Supera Stent in Common Femoral Artery Disease
August 8, 2020—Belgium-based iD3 Medical announced that the first two patients were enrolled in the physician-initiated, prospective, multicenter, randomized SUPERSURG study investigating the safety and efficacy of the Supera peripheral stent system (Abbott) versus surgical endarterectomy in treating patients with common femoral artery disease (with and without femoral bifurcation involvement).
News | 08.05.20
News | 07.27.20
Results From REACH PVI Study of CSI's Transradial Orbital Atherectomy Systems in Lower Extremities Presented
July 27, 2020—Cardiovascular Systems, Inc. announced that procedural data from its REACH PVI study were presented at NCVH 2020: New Cardiovascular Horizons 21st annual conference, held as part of the NCVH digital education series.
US Device Guide
This Device Guides offers a searchable, comprehensive listing of the available vascular interventional devices in the United States.
European Device Guide
This Device Guides offers a searchable, comprehensive listing of the available vascular interventional devices in Europe.