News

BB Medical Surgical Thixo-Gel FDA Clearance Ultrasound Systems

The U.S. Food and Drug Administration (FDA) recently cleared BB Medical Surgical’s Thixo-Gel, which is sprayed on to the patient to enable quicker and easier ultrasound scans. 

Medtronic Inc. announced CE mark and launch of the NC Euphora noncompliant balloon dilatation catheter. 

Strokes kill nearly 130,000 Americans every year, according to the Centers for Disease Control and Prevention. Because approximately 30 percent of strokes are caused by blockages in the carotid...

June 3, 2014 — Edwards Lifesciences Corp. received CE mark for the advanced Edwards Intuity Elite valve system. The next-generation, rapid deployment system facilitates smaller incisions in...

June 3, 2014 — JenaValve Technology Inc., a privately held, venture-backed developer of transcatheter aortic valve implantation (TAVI) systems for the treatment of aortic valve disease, announced...

June 3, 2014 — The U.S. Food and Drug Administration (FDA) announced it approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death and need for...

Simbionix ANGIO Mentor Flex Endovascular Training

As more endovascular medical programs adapt simulation as an essential part of their training curriculum, there is a constant and consistent need for updated simulation solutions. Simbionix is...

June St. Jude Medical Inc. announced preliminary results from the EnligHTN III study, which found the company’s second-generation EnligHTN renal denervation system provided safe and effective...

Direct Flow Medical has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate the pivotal phase of the SALUS trial. The SALUS trial...

CardiAQ Valve Technologies announced it successfully implanted its second-generation transcatheter mitral valve (TMVI) using the company’s newly added transapical delivery system. The transapical...

2013 Ultrasound Market Report Klein Biomedical Consultants Inc.

According to The Medical Diagnostic Ultrasound Market in the USA: Challenges & Opportunities in the New Millennium, 2013 report, the U.S. ultrasound market grew almost 3 percent last year...

CardioMEMS Heart Failure System FDA Approval

The U.S. Food and Drug Administration (FDA) granted market clearance to the CardioMEMS Heart Failure System, the first FDA-approved heart failure (HF) monitoring device shown in clinical trials to...

Boston Scientific REPRISE II Clinical Trial Six-month Results Lotus Valve

Further validating its advanced transcatheter aortic valve implantation (TAVI) technology, the Boston Scientific Corp. Lotus Valve System continued to demonstrate impressive performance at six...

As a cardiovascular technology magazine editor, I keep tabs on what technology is in development and often have the opportunity to see the most cutting edge technology up close prior to U.S. Food...

Direct Flow Medical Transcatheter Aortic Valve 12-month Outcomes

Direct Flow Medical Inc. announced 12-month outcomes from the DISCOVER CE mark clinical trial.

May 27, 2014 — Ekos Corp. announced the U.S. Food and Drug Administration (FDA) has cleared the EkoSonic endovascular system for the ultrasound-facilitated, controlled and selective infusion...

Terumo BCT has entered into a business relationship with Kaneka to gain market authorization in the United States for the use of the Terumo BCT Spectra Optia Apheresis System with the Kaneka...

May 23, 2014 — Stentys presented final results from the APPOSITION IV study of its new self-apposing sirolimus-eluting stent (SES) during the Hotline session at the EuroPCR conference in Paris.

May 23, 2014 — The first drug-eluting balloon to go up for review by the U.S. Food and Drug Administration (FDA) will be discussed at the next Circulatory System Devices Panel of the Medical...

Journal of Endovascular Therapy Hypertension Renal Denervation Therapy

Patients with hypertension after renal artery stenting who do not respond to drug treatment may have another option.