Peripheral/Endo

FDA Clears 12 New XO Cross Microcatheters

12 new hydrophilic-coated micro and support catheters cleared by FDA for broad use in the peripheral vasculature. PARK CITY, Utah, Nov. 2, 2021 /PRNewswire/ — Transit Scientific announced the FDA clearance of new hydrophilic-coated XO Cross Microcatheters for guidewire support, exchange, and contrast media injection in the peripheral vasculature. “The XO Cross devices […]

Inari Medical Announces 6-month FLASH Registry Interim Data Demonstrating Benefits of Lytic-Free Mechanical Thrombectomy in 500 Real-World PE Patients

IRVINE, Calif., Oct. 28, 2021 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases, today announced positive acute and long-term interim results from the first 500 pulmonary embolism (“PE”) patients […]

Use of a Novel, Intermittent Pneumatic Compression Device to Promote Perforator Vein Dilation in Patients with Chronic Renal Failure: The pFACT Trial

October 2021 ISSN 2152-4343 Abstract Objective. Arteriovenous fistula (AVF) creation is an important procedure for hemodialysis in chronic renal failure (CRF) patients. Recent advancements in vascular access have resulted in endovascular AVF (endoAVF) creations. EndoAVFs are less invasive and less expensive when placed. The dilation of the perforator vein pre-procedure is crucial […]

Inari Medical Announces Randomized Controlled Trial Evaluating Clinical Outcomes of the FlowTriever® System in Pulmonary Embolism Patients

IRVINE, Calif., Oct. 18, 2021 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases, announced planned enrollment of the PEERLESS trial. PEERLESS is a new randomized controlled trial (RCT) comparing […]

InspireMD Receives Reimbursement Approval for CGuard™ Embolic Prevention System from the French National Authority for Health

TEL AVIV, Israel, Oct. 13, 2021 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), a global developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announced that its CGuard EPS stent system has received a positive opinion from […]

18-Month Below-the-Knee Data with MedAlliance’s SELUTION SLR™ Presented as Late Breaking Trial at VIVA

GENEVA, Oct. 8, 2021 /PRNewswire/ — 18-month results from the PRESTIGE* Below-the-Knee (BTK) study have been presented as a Late Breaking Clinical Trial at VIVA21. The objective of this clinical investigation has been to evaluate safety and performance outcomes of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, for the treatment of long tibial occlusive lesions […]

Venclose MAVEN Earns FDA Clearance to Treat Incompetent Perforator Veins

Next-generation radiofrequency catheter offers first thermal ablation perforator treatment advancement in over 10 years SAN JOSE, Calif., Oct. 7, 2021 /PRNewswire/ — Venclose Inc., a privately-held Silicon Valley medical device company focused on innovative treatment procedures for venous reflux disease today announced FDA 510(k) clearance for Venclose Maven™, a novel radiofrequency ablation […]

Artio Medical’s Amplifi™ Vein Dilation System Highlighted at 2021 VIVA Conference

First-of-its-kind technology demonstrates exceptional initial results in hemodialysis patients PRAIRIE VILLAGE, Kan., Oct. 7, 2021 /PRNewswire/ — Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and structural heart markets, today announced that preliminary clinical results from its first-in-human study of the Amplifi™ Vein Dilation System were presented […]

Late-breaking Data From PROMISE I Study On LimFlow System Confirm Excellent Sustained Outcomes In Patients With No-option Chronic Limb-threatening Ischemia

Limb salvage in 77 percent of patients at 2 years with “no-option” for revascularization via traditional techniques 24-Month Results Presented Wednesday at VIVA 2021 Conference SAN JOSE, Calif. and LAS VEGAS, Oct. 7, 2021 /PRNewswire/ — LimFlow SA, the pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a […]

BD Announces 510(k) Clearance of Expanded Indications for the Rotarex™ Atherectomy System

Rotarex™ Rotational Excisional Atherectomy System is the first and only atherectomy and thrombectomy device indicated to treat in-stent restenosis in the United States FRANKLIN LAKES, N.J., Oct. 6, 2021 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received 510(k) clearance for expanded indications from the […]