October 10, 2017 07:00 AM Eastern Daylight Time FREMONT, Calif.–(BUSINESS WIRE)–Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today reported $35 million in new financing, an extension of the company’s previously announced $45 million Series C financing. New investor Fidelity Management & Research Company participated, along with […]
Peripheral/Endo
Medtronic (MDT)’s Stent System Wins FDA OK to Treat Short Neck Anatomies When Used With Heli-FX EndoAnchor System
DUBLIN – October 9, 2017 – Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the Endurant(TM) II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients with neck lengths down to 4mm and <=60° infra-renal angulation when used in combination […]
Endologix Receives IDE Approval For The EVAS2 Confirmatory Clinical Study To Evaluate The Nellix Endovascular Aneurysm Sealing System
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption (“IDE”) approval from the United States Food and Drug Administration (“FDA”) to commence a confirmatory clinical study to evaluate the safety and effectiveness of the Nellix […]
BTG to buy Roxwood Medical for up to $80 million
UK’s BTG to buy Roxwood Medical for up to $80 million Reuters Staff Reporting by Radhika Rukmangadhan in Bengaluru; editing by Jason Neely Our Standards:The Thomson Reuters Trust Principles. (Reuters) – British drugs company BTG Plc (BTG.L) said on Thursday it will buy U.S.-based cardiovascular catheter maker Roxwood Medical for […]
ROX Medical CONTROL HTN-2 Clinical Trial; First Procedure Performed
SAN CLEMENTE, Calif., October 3, 2017 – ROX Medical Inc. A privately held medical device company pioneering an innovative interventional vascular therapy for Uncontrolled Hypertension, announced today that the first patient was treated in the CONTROL HyperTeNsion (HTN)-2 clinical study, the Company’s pivotal study to evaluate the safety and effectiveness of […]
Bolton Medical Announces the First Implant of the Relay®Pro Clinical Trial for Treatment of Thoracic Aortic Dissections
Sunrise, Fla, October 3, 2017 – Bolton Medical announced the first patient has been enrolled in the RelayPro FDA Phase II Clinical Trial for Treatment of Acute Complicated Type B Thoracic Aortic Dissections. This trial will assess the safety and efficacy of RelayPro to treat Type B dissections. Christian Shults, M.D., Cardiothoracic […]
Celebrating The 20th Anniversary Of The W. L. Gore & Associates EXCLUDER Device
FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) today announced the 20th anniversary of the first implant of the GORE® EXCLUDER® AAA Endoprosthesis, the most-studied** endovascular aneurysm repair (EVAR) device on the market, with more than 300,000 patients treated* worldwide. The GORE EXCLUDER Device provides physicians with a proven and durable option to […]
FDA Warns Physicians on Endoleaks With Stent Grafts
Endovascular Graft Systems: Letter to Health Care Providers – Type III Endoleaks Associated with Use [Posted 09/28/2017] AUDIENCE: Risk Manager, Surgery, Cardiology, Radiology ISSUE: The FDA is evaluating recent information regarding Type IIIa and IIIb endoleaks with the use of endovascular graft systems indicated for a procedure known as endovascular […]
Avinger Receives CE Marking Approval for In-Stent Restenosis Treatment Indication With Pantheris Image-Guided Atherectomy
REDWOOD CITY, Calif., Sept. 26, 2017 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced Conformité Européenne (CE) Marking approval for treating in-stent restenosis with the Pantheris® Lumivascular atherectomy system. In-stent restenosis occurs when a previously blocked artery treated with […]
TVA Medical Receives CE Mark For Next-Generation everlinQ 4 endoAVF System
AUSTIN, Texas, Sept. 27, 2017 /PRNewswire/ — TVA Medical, Inc., a medical device company developing innovative therapies for end-stage renal disease (ESRD), today announced that its everlinQTM 4 endoAVF System has received CE Mark in the European Union. The technology uses a 4 French catheter system with enhanced visual indicators to create hemodialysis access […]