Author: Ken Dropiewski

Corindus Announces Opening of First International Robotic Training Center

WALTHAM, Mass.–(BUSINESS WIRE)–Corindus Vascular Robotics, Inc. [NYSE American: CVRS], a leading developer of precision vascular robotics, announced today the opening of the first international CorPath GRX Robotic Center in Tokyo, Japan. Earlier this year, Corindus partnered with Japan Medicalnext Co., Ltd., a wholly-owned entity of MC Healthcare, Inc. (subsidiary of […]

CardioFocus® Announces European CE Mark Approval Of The Next-Generation HeartLight® Excalibur Balloon™ Designed For The Treatment Of Atrial Fibrillation

MARLBOROUGH, Mass., Sept. 27, 2017 /PRNewswire/ — CardioFocus, Inc. today announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF). The Excalibur Balloon leverages the proven universal balloon design of the company’s FDA-approved HeartLight® Endoscopic Ablation System and introduces an advanced feature set that optimizes the speed […]

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 […]

BioCardia Announces Successful Interim Safety Analysis In Its Phase III Clinical Trial Of Cardiamp Stem Cell Therapy For Heart Failure

SAN CARLOS, Calif.–(BUSINESS WIRE)–BioCardia (OTC: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed the pre-specified interim analysis of safety outcomes for the first 10 patients treated in the Phase 3 trial of its […]

How Stopping Aspirin Can Increase Risk of Cardiac Event by Almost 40%

By Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) An aspirin a day has been a standard recommendation for those diagnosed with certain types of coronary disease for decades. However, knowing patients like we do, medication non-compliance is a real problem -especially when it comes to recommended non-prescription drugs. So, what happens […]

Lombard Medical’s New Delivery System for Aorfix™ Endovascular Aortic Aneurysm Repair System Launched in Japan

OXFORDSHIRE, England–(BUSINESS WIRE)–Lombard Medical, Inc. (NASDAQ: EVAR), a developer, manufacturer and marketer of endovascular abdominal aortic aneurysm (AAA) endovascular repair products, today announced the full commercial launch in Japan of its new low-profile IntelliFlex™ LP delivery system for the Aorfix™ AAA system. The new delivery system, used to deliver Lombard’s […]

Reflow Medical Announces 510(k) Clearance to Market Wingman Crossing Catheter for Coronary Indication

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a developer and innovator of crossing and support catheters for use in the treatment of occlusive cardiovascular disease, announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Wingman14C Crossing Catheter for use in conjunction […]

TherOx Announces Its PMA Application for AMI Therapy System is Accepted for Filing by FDA

IRVINE, Calif.–(BUSINESS WIRE)–TherOx, Inc., a privately held medical device company focused on improving treatment of Acute Myocardial Infarction (AMI), announced that the U.S. Food and Drug Administration (FDA) has accepted the Premarket Approval (PMA) application for its Supersaturated Oxygen (SSO2) Therapy system. The second-generation SSO2 Therapy system is designed to reduce […]

BioStable Science & Engineering Announces the First Commercial Use of the HAART 200™ Aortic Annuloplasty Device

AUSTIN, Texas–(BUSINESS WIRE)–BioStable Science & Engineering, Inc. announced today the first commercial use of the HAART 200 Aortic Annuloplasty Device in the U.S. by doctors at the West Virginia University (WVU) Heart and Vascular Institute in Morgantown, West Virginia. Drs. Lawrence Wei, Vinay Badhwar and J. Scott Rankin were the […]

MicroVention Celebrates Grand Opening Of New Worldwide Innovation Center In Aliso Viejo, California

ALISO VIEJO, Calif., Sept. 26, 2017 /PRNewswire/ — MicroVention, a wholly owned subsidiary of Terumo Corporation and a global neurovascular company, today announced that the Grand Opening of its New Innovation Center was held on Monday, September 25. The opening of the new facility, located in the heart of the Summit Office Campus, also […]