CAESAREA, Israel, Sept. 6, 2017 /PRNewswire/ — Gardia Medical, an Israeli Medical Device Company focused on embolic protection solutions, announced that according to the independent Clinical Events Committee (CEC), Gardia successfully met the primary end-point in its WISE-LE study. The WISE-LE study’s objective is to demonstrate the safety and performance of the […]
Peripheral/Endo
Spectranetics Recalls Bridge Occlusion Balloons
Philips subsidiary Spectranetics recalls Bridge occlusion balloon AUGUST 31, 2017 BY BRAD PERRIELLO , MassDevice Royal Philips (NYSE:PHG) subsidiary Spectranetics recalled its Bridge occlusion balloon after receiving reports of blocked guidewire lumens. The Bridge device is used to temporarily block the superior vena cava for emergency control of hemorrhage. Spectranetics said the August 25 recall was […]
PQ Bypass Earns Frost & Sullivan’s European Technology Innovation Award for Its Proprietary DETOUR System for Percutaneous Bypass
LONDON, Aug. 31, 2017 /PRNewswire/ — Frost & Sullivan is pleased to recognize PQ Bypass with the 2017 European PAD Interventions Technology Innovation Award. PQ Bypass’ DETOUR System is a minimally invasive technology that enables physicians to re-direct, or detour, blood flow around extremely long blockages in the upper leg arteries to restore […]
Balloon Expandable Stents OUT for Treatment of Peripheral Vascular Disease?
by Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) Balloon expandable stents have been the mainstay in treating blockages in the iliac arteries for years. However, recent data suggests a change is in order. According to researchers who recently compared the two versions in a large group of patients being treated in […]
Medtronic Plans for Renal Denervation Pivotal Trial After New Study Shows Significant Blood Pressure Reductions
Published Simultaneously in The Lancet, the Late-Breaking SPYRAL HTN-OFF MED Study at ESC Successfully Isolates RDN Treatment Effect to Show Compelling Efficacy and Safety of Hypertension Procedure DUBLIN and BARCELONA – August 28, 2017 – Medtronic plc (NYSE:MDT) today announced its intent to move forward with a new renal denervation pivotal trial […]
C. R. Bard, Inc. (BCR) Snags FDA Premarket Approval of The Lutonix 035 Drug Coated Balloon As The First And Only DCB
C. R. Bard Receives Fda Premarket Approval Of The Lutonix® 035 Drug Coated Balloon As The First And Only Dcb For The Treatment Of Patients With Dysfunctional Av Fistulae New Option to Preserve Vascular Access and Help Hemodialysis Patients Extend Time Between Reinterventions MURRAY HILL, N.J.–(BUSINESS WIRE)–C. R. Bard, Inc. […]
Ra Medical Looks for Potential IPO in Early 2018
Ra Medical finally received FDA approval this year after three years, now they will be shooting for an IPO. Ra Medical CEO Irwin aims for Feb 2018 IPO AUGUST 24, 2017 BY FINK DENSFORD, MassDevice In May, Ra Medical received a nod from the FDA for its Dabra arteriosclerosis laser, clearing it for use in the […]
Malin Announces U.S. FDA Approval for New Hourglass™ Peripheral Embolisation Plug
DUBLIN–(BUSINESS WIRE)–Malin Corporation plc. (ISE:MLC, “Malin”), an Irish based and globally operating life sciences company, today announced that its EMBA device, known as the Hourglass™ Peripheral Embolisation Plug, was granted U.S. FDA 510(k) clearance to commence marketing in the US. The Hourglass™ peripheral embolisation plug represents a breakthrough in peripheral […]
Getinge Announces Full U.S. Availability Of Pulsar-18 Self-Expanding Stent From BIOTRONIK For Patients With Peripheral Artery Disease
WAYNE, N.J., Aug. 22, 2017 /PRNewswire/ — Getinge, a leading global provider of innovative medical technology, today announces the full U.S. market release of the Pulsar®-18 stent from BIOTRONIK. Pulsar-18 is the only available self-expanding stent for blocked superficial femoral arteries with a 4-French (4F) delivery system. Getinge currently distributes BIOTRONIK’s portfolio of […]
Endologix Announces Positive Clinical Results From The LEOPARD Clinical Study
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (NASDAQ:ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced positive interim results from the LEOPARD (Looking at Evar Outcomes by Primary Analysis of Randomized Data) clinical study. LEOPARD is the first and only head-to-head, prospective, multi-center, randomized clinical study comparing currently available endovascular abdominal aortic stent grafts. LEOPARD […]



