News

August 28, 2014 — Renal artery stenting to open blockages in the kidney arteries may benefit patients who have historically been excluded from modern clinical trials, according to new...

August 27, 2014 — Philips Healthcare announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its precision planning application for transcatheter...

Hemostasis Biolife StatSeal Advanced Disc Cath Lab

Cath Labs, interventional radiology suites and hospitals are continually trying to improve patient comfort as well as save time and reduce costs. With these goals in mind, Biolife introduces...

Columbia University Univ. South Florida Clinical Trial Therapy Artery Repair

A new therapy developed by researchers at the University of South Florida (USF) Morsani College of Medicine and Columbia University Medical Center (CUMC) may help reduce the life-threatening...

August 21, 2014 — Efforts over the past decade to improve the quality of care for cardiovascular disease patients and increase the use of evidence-based treatments have led to a significant drop...

August 21, 2014 — Corindus Vascular Robotics announced the results of a retrospective study comparing use of radiation and contrast for patients enrolled in its CorPath PRECISE (Percutaneous...

Cardiva Medical Inc. Vascade Vascular Closure System Series 3 financing U.S.

Cardiva Medical Inc. said it closed the first two tranches of a $16.5 million Series 3 private equity financing and a $12.5 million senior secured facility with GE Capital. The company will use...

U.S. Department of Justice Close Investigation PLATO Clinical Trial Ticagrelor

AstraZeneca announced it has received confirmation from the United States Department of Justice that it is closing its investigation into PLATO, a clinical trial that tested the safety and...

Boston Scientific Corp. and Asahi Intecc have formalized plans to develop a new, differentiated fractional flow reserve (FFR) wire. 

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...

 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...

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...

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...

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....