Peripheral/Endo

JanOne taps distinguished chemist Dr. Doug Flanagan as chief formulation advisor

Dr. Flanagan, an accomplished chemist and formulation specialist, leads manufacturing and clinical development of JanOne’s PAD candidate TV1001SR LAS VEGAS, June 25, 2020 /PRNewswire/ — JanOne Inc. (NASDAQ: JAN), a company focused on bringing treatments to market for conditions that cause severe pain and drugs with non-addictive pain relieving properties, continues to build […]

NeuroMetrix Signs DPNCheck® Collaboration Agreement with Biomedix

WOBURN, Mass., June 25, 2020 (GLOBE NEWSWIRE) — NeuroMetrix, Inc. (Nasdaq: NURO) today reported that it has signed a collaboration agreement with Biomedix to comarket DPNCheck for peripheral neuropathy detection within Medicare Advantage and other value-based care markets. NeuroMetrix and Biomedix provide complementary diagnostic tests to physicians and health plans. […]

InspireMD Announces Late-Breaking Presentation of Early SIBERIA Clinical Trial Results to be Featured in an e-Course at EuroPCR

In a head-to-head evaluation, significantly fewer silent brain infarcts were associated with CGuard™ EPS versus Acculink™ at 30 days post-procedure TEL AVIV, Israel, June 25, 2020 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid […]

ABRE Study Meets Primary Safety and Effectiveness Endpoints

Medtronic Self-Expanding Venous Stent Demonstrates Favorable Outcomes in Patients with Venous Outflow Obstruction DUBLIN and LONDON, June 16, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the first-ever results from the ABRE clinical study assessing the safety and effectiveness of the investigational Abre™ venous […]

INFINITY ANGIOPLASTY BALLOON CATHETER™ RECEIVES 510(k) CLEARANCE

[Dateline: Toledo, Ohio, June, 2020]-INFINITY ANGIOPLASTY BALLOON CO., announced today that its innovative balloon platform – INFINITY ANGIOPLASTY BALLOON CATHETER™ has been cleared by the FDA for PTA treatment of peripheral arterial disease, in peripheral vasculature including iliac, femoral, popliteal, infra-popliteal arteries and for the treatment of AV dialysis fistulae.   […]

Endologix Issues Correction Notice for Ovation iX Abdominal Stent Graft System

IRVINE, Calif.–(BUSINESS WIRE)–Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA […]

Contego Medical Announces the Start of Enrollment in the PERFORMANCE II Carotid Stenting Clinical Trial

RALEIGH, N.C., June 15, 2020 /PRNewswire/ — Contego Medical, Inc. today announced enrollment of the first patient in the PERFORMANCE II Trial evaluating the safety and effectiveness of the Neuroguard IEP® 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection. The Neuroguard IEP System is designed to treat […]

Reflow Medical Enrolls First Patients in the DEEPER LIMUS Study of the Temporary Spur Stent System

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a California-based medical device company, has enrolled the first patients in A Non-RanDomized Pilot Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base Drug-coated Balloon (DEEPER LIMUS). The OUS single center clinical trial […]

InspireMD Announces Publication of 12-Month Results of CGuard™ EPS PARADIGM Trial in EuroIntervention

Results indicate that 12 months after carotid intervention the CGuard EPS MicroNET-covered stent delivers sustained protection against postprocedural neurologic events TEL AVIV, Israel, June 10, 2020 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid […]

Saranas Announces Peer-Reviewed Publications Highlighting Accuracy and Clinical Utility of Early Bird® Bleed Monitoring System

HOUSTON–(BUSINESS WIRE)–Saranas, Inc., developer of the Early Bird® Bleed Monitoring System for the monitoring and early detection of internal bleed complications during endovascular procedures, announced the online publication of two peer-reviewed articles highlighting the system’s accuracy and performance. The publications provide evidence of the Early Bird’s reliability to detect the early […]