Janssen Seeks New Indication to Expand Use of Xarelto in PAD
October 26, 2020—The Janssen Pharmaceutical Companies of Johnson & Johnson announced it has submitted a supplemental New Drug Application to the FDA for a new indication to expand the use of Xarelto (rivaroxaban) in patients with peripheral artery disease (PAD).
FDA Clears In-Stent Restenosis Indication for VentureMed’s Flex Vessel Prep System
October 21, 2020—VentureMed Group, Inc., announced that the FDA cleared a new indication for the company’s Flex vessel preparation (VP) system for use in the treatment of in-stent restenosis (ISR) in the peripheral vasculature.
Continuing Coverage: Paclitaxel In PAD
Subgroup Analysis of VOYAGER PAD Trial Finds No Mortality Risk or Benefit Associated with Drug-Coated Devices in PAD Treatment
October 18, 2020—A large subgroup analysis of the VOYAGER PAD randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices in the treatment of peripheral artery disease (PAD).
9-Month Data Presented From IN.PACT BTK Feasibility Study of Medtronic's In.Pact DCB to Treat CLI
October 18, 2020—Medtronic announced the first results from IN.PACT BTK, a feasibility study assessing the safety and effectiveness of the company's In.Pact 0.014 drug-coated balloon (DCB) in critical limb ischemia (CLI) patients with chronic total occlusion (CTO) in the infrapopliteal arteries.
Ra Medical Systems Continues Pivotal Atherectomy Clinical Trial of DABRA System
October 14, 2020—Ra Medical Systems, Inc. announced the resumption of its pivotal clinical trial evaluating the safety and effectiveness of the DABRA excimer laser system as an atherectomy device for the treatment of peripheral artery disease (PAD).
WaveClear Raises Funding for Development of CaviClear Ultrasound-Generated Cavitation System
October 13, 2020—WaveClear, Inc., a medical device start-up developing therapeutic ultrasound technologies to treat vascular diseases, announced the closing of funding that will be used to further develop the company’s CaviClear endovascular system, a minimally invasive ultrasound-generated cavitation device for a broad range of endovascular applications.
Enrollment Begins for MedAlliance’s PRISTINE Registry of the Selution SLR Sirolimus-Eluting Balloon
October 12, 2020—MedAlliance announced that the first two patients have been enrolled in the PRISTINE registry, which is evaluating the company’s Selution SLR (sustained limus release) sirolimus drug-eluting balloon for the treatment of patients with chronic limb-threatening ischemia (CLTI).
CDC Recognizes and Codifies CLI and CLTI in ICD-10-CM
October 5, 2020—A coalition organized by the CLI Global Society announced that its proposal to distinctly recognize “critical limb ischemia” (CLI) and “chronic limb-threatening ischemia” (CLTI) in the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) was approved by the Centers for Disease Control and Prevention and went into effect October 1.
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).
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.
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.
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.
Sponsored by AngioDynamics, Inc.
Sponsored by Cagent Vascular
Exploring Serration-Enhanced BTK Angioplasty
Investigators share case-based perspectives and trial experiences with the Serranator PTA Serration Balloon Catheter, now FDA-cleared for use below the knee.
With Michael Lichtenberg, MD, FESC; Andrew Holden, MBChB, FRANZCR, EBIR; and Marianne Brodmann, MD
Roundtable Discussion: Office-Based Vascular Practices During the COVID-19 Pandemic
A discussion about how COVID-19 has affected the office-based practice, including procedure volume shifts, protocol changes and safety procedures, hospital referrals, and follow-up scheduling.
With Bryan Fisher, MD; Mark J. Garcia, MD, MS, FSIR, FACR; Yazan Khatib, MD, FACC, FSCAI, FABVM, FSVM; and Sonya Noor, MD, FACS
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.