Peripheral/Endo

PQ Bypass Receives IDE Approval to Initiate Study of First-of-its-Kind Procedure for Patients Suffering From Peripheral Artery Disease

SUNNYVALE, Calif.–(BUSINESS WIRE)–PQ Bypass, Inc., today announced it has received conditional approval of its investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate the pivotal DETOUR II clinical trial. As the first-ever pivotal trial for percutaneous femoropopliteal bypass, DETOUR II will evaluate the safety and […]

Janssen Submits Supplemental NDA to FDA Seeking New Indications for XARELTO (rivaroxaban) for Patients With Chronic Coronary and/or Peripheral Artery Disease (CAD/PAD)

RARITAN, N.J., Dec. 11, 2017 /PRNewswire/ — Janssen Research & Development today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new XARELTO® (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke […]

PVD Patients Boomeranging at Higher Rates After Intervention, Study Shows

By Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) As we progress to value-based healthcare system, it’s more important than ever to keep readmissions to a minimum. A recent study, though, found that more than 17 percent of patients undergoing peripheral revascularization for PVD were readmitted within 30 days of having the procedure.The unplanned […]

Updated TCAR Data From Silk Road Medical’s ROADSTER 1 and 2 Studies Presented at VEITHsymposium

SUNNYVALE, Calif., Nov. 29, 2017 /PRNewswire/ — Silk Road Medical, a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced multiple presentations at the 45th annual VEITHsymposium highlighting the safety and efficacy of the company’s ENROUTE® Transcarotid Neuroprotection and Stent System, the first and only products specifically designed and […]

Vascular Flow Technologies Forges Strategic Partnership With Biovic to Develop the New Avatar SLF Vascular Graft

DUNDEE, Scotland, November 21, 2017 /PRNewswire/ — Vascular Flow Technologies, the medical device company who developed the proprietary Spiral Laminar Flow (SLF(TM)) technology to re-establish natural blood flow for enhanced patient outcomes, today announces the successful conclusion of a strategic intellectual property out-licencing agreement with Biovic Sdn bhd. Biovic are […]

Cagent Vascular Wins CE Mark for Serranator, a Next Generation Device for Vessel Dilatation in PAD Interventions

WAYNE, Pa.–(BUSINESS WIRE)– Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular disease interventions, announces the issuance of its CE Marking for the Serranator® PTA Serration Balloon Catheter. Cagent Vascular has also achieved its ISO 13485 Certification. The Serranator® is one of a family of peripheral artery disease (PAD) […]

Positive Twenty-Four Month Tack Optimized Balloon Angioplasty (“TOBA”) Single Center Results Presented at VEITHsymposium™ Conference

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally-invasive peripheral vascular procedures, today announced that positive single center twenty-four month results from its Tack Optimized Balloon Angioplasty (TOBA) clinical study were presented at the VEITHsymposium™ 2017 conference by Dr. Christian Wissgott, Assistant Director, at Westküstenklinikum Heide in Heide, Germany. The TOBA study enrolled […]

Aziyo Presents Positive Initial Data From Clinical Study of Biologic Extracellular Matrix Scaffold for Femoral Arterial Reconstruction

SILVER SPRING, Md.–(BUSINESS WIRE)– Aziyo Biologics, a fully integrated regenerative medicine company, today announced positive results from PERFORM, a prospective, post-market study conducted in patients undergoing femoral arterial reconstruction using the company’s biologic extracellular matrix (ECM) scaffold. There were no device-related adverse events or infections and primary patency was maintained in 97.6% of […]

Medtronic gains new CPT codes for Venous device in 2018

Medtronic’s VenaSeal Closure System Receives New CPT Codes By Endovascular Today November 13, 2017—Medtronic has advised that their VenaSeal closure system received a favorable new CPT code as a Level 4 vascular procedure as part of the calendar year 2018 Medicare Physician Fee Schedule and Hospital Outpatient Prospective Payment and Ambulatory Surgical Center […]