News

Cardiovascular Systems is recalling certain lots of the Diamondback 360 Peripheral Orbital Atherectomy System, because they may contain defective saline sheaths that could fracture during use. If...

Bluegrass Vascular Technologies closed $4.5 million in Series A financing, that will allow the company to obtain CE mark for the Surfacer Inside-Out Access Catheter System. 

Transcatheter Cardiovascular Therapeutics 2014 Infinix X-ray Toshiba

At the Transcatheter Cardiovascular Therapeutics (TCT) 2014 meeting Sept. 13-17, Toshiba will display newer features offered on its Infinix cardiovascular X-ray system to improve diagnostic...

August 18, 2014 — Two Mount Sinai research studies in the August issue of the Journal of the American College of Cardiology (ACC): Cardiovascular Imaging show the potential of using tele-...

 Polidocanol injectable foam Varithena Varicose Veins

Polidocanol injectable foam (Varithena), the only U.S. Food and Drug Administration (FDA)-approved foam for the treatment of incompetent great saphenous veins (GSV), accessory saphenous veins and...

August 15, 2014 — Mardil Medical announced earlier this year the first-in-human implants using the VenTouch ventricular reshaping device performed by a surgical team at the Institut...

MYDICAR Celladon Corp. Clinical Trial Heart Failure Treatments LVADs

Celladon Corp. announced that the first patient has been dosed in a clinical trial titled "Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Patients with Heart Failure...

August 12, 2014 — The Centers for Medicare and Medicaid (CMS) took action to improve access to Abbott’s MitraClip system after issuing its fiscal year 2015 ruling on the inpatient prospective...

Teleflex Inc.’s subsidiary Hotspur Technologies Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the Arrow GPSCath Balloon Dilatation Catheters designed for use...

August 11, 2014 — Toshiba America Medical Systems is making it possible for clinicians to use ultrasound to see the smallest vessels in and around areas like tumors and lymph nodes, giving them a...

Imaging experts from the American Society of Echocardiography (ASE) released a paper, "Guidelines for the Cardiac Sonographer in the Performance of Contrast Echocardiography: A Focused Update from...

SynCardia Total Artificial Heart SynHall Valves FDA approval

SynCardia Systems Inc. received approval in July from the U.S. Federal Drug Administration (FDA) for the SynCardia temporary Total Artificial Heart with SynHall valves, giving the company control...

Biotronik Enrollment Completion SFA Arm BIOFLEX-I Study Pulsar-18 4-French

Biotronik announced the completion of patient enrollment in the superficial femoral artery (SFA) arm of its BIOFLEX-I clinical trial, an U.S. Food and Drug Administration (FDA)-approved...

August 7, 2014 — The Berlin Heart Group announced they have completed enrollment in their post-approval study, the only condition of the humanitarian device exemption (HDE) approval that...

Transluminal Technologies LLC CE mark velox CD Vascular Closure Device

Transluminal Technologies LLC, a Syracuse, NY-based medical device company, received CE mark approval for the velox CD Vascular Closure Device. 

Medtronic, Acist Agreement FFR-IVUS Technologies

Acist Medical Systems entered into a strategic agreement with Medtronic to co-promote the world’s first Rapid Exchange FFR (RXi) and high definition IVUS (HDi) technologies in the United States....

Decision Resources Group finds that the United States clot management device market will expand through 2022, particularly in the later years. 

August 5, 2014 — A survey, published online in the European Journal of Cardio-Thoracic Surgery, of 13,860 patients who had undergone interventions for aortic valve disease in Germany...

SynCardia Total Artificial Heart Implant VAD Heart Failure Treatments

For the first time, cardiac surgeons, medical professionals and the public can watch the implantation of the SynCardia temporary Total Artificial Heart in a peer reviewed case report paper and...

Sorin Group Solo Smart Heart Valve Repair

Sorin Group received U.S. Food and Drug Administration (FDA) approval for the Solo Smart Aortic Pericardial Heart Valve.