News

Boston Scientific, Safari2 pre-shaped guidewire, cath lab, TAVI, TAVR, FDA, CE

Boston Scientific announced CE Mark and U.S. Food and Drug Administration (FDA) clearance for the Safari2 Pre-Shaped Guidewire. Safari2 is an enhanced version of the  Safari Guidewire,...

The Medicines Company, Angiomax, generic launch, Sandoz Inc.

The Medicines Company announced an agreement July 9 with Sandoz Inc. for the distribution of an authorized generic of Angiomax (bivalirudin) for injection in the United States.

CSI, ViperWire Advance Peripheral Guide Wire with Flex Tip, Stealth, Diamondback

Cardiovascular Systems Inc. announced that it has received U.S. Food and Drug Administration (FDA) clearance for its new ViperWire Advance Peripheral Guide Wire with Flex Tip for their peripheral...

The Medicines Company, bivalirudin, Angiomax, litigation, Hospira Inc.

The Medicines Company announced the U.S. Court of Appeals for the Federal Circuit Court has ruled against the company in its bivalirudin (Angiomax) patent litigation with Hospira Inc.

GlobalData, TAVR, Edwards, Medtronic, CoreValve Evolut R, Sapien 3

The recent U.S. Food and Drug Administration (FDA) approvals of two next-generation transcatheter aortic valve replacements (TAVR) devices will transform the U.S. market for TAVR procedures over...

Boston Scientific, fully absorbable scaffold, FAST study, resorbable

Boston Scientific has initiated a study of the company's first fully resorbable drug-eluting scaffold system. The Fully Absorbable Scaffold Feasibility Study (FAST) is a prospective, single-arm...

Veryan Medical, BioMimics 3D femoropopliteal stent, MIMICS-2 study, PAD

Veryan Medical announced that the first subject has been enrolled in their MIMICS-2 study at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany by the European principal investigator,...

cardiac rehab after angioplasty, rehabilitation, ACC, Randal J. Thomas, referral

Hospitals in the Midwest were more likely than others to refer patients for guideline-recommended cardiac rehabilitation following angioplasty, according to new original research. This is...

ACC, health policy statement, heart team, cardiovascular health

Building teams that include advanced practice providers can help cardiovascular practices meet the challenges of modern practice, according to a new health policy statement by the American College...

Medtronic, Protege GPS self-expanding peripheral stent, FDA approval

Medtronic plc announced that its Protégé GPS self-expanding peripheral stent system has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of stenotic lesions of...

Thoratec, HeartMate PHP. CE Mark approval, SHIELD I

Thoratec announced that the HeartMate PHP (Percutaneous Heart Pump) received CE Mark approval, permitting sale in the European Union and other international countries. Approval was based on data...

carotid artery stenting, outcomes, JACC, Beau Hawkins, Robert Yeh, CARE Registry

Hospitals performing carotid artery stenting vary considerably in rates of in-hospital stroke or death, according to a study published in JACC: Cardiovascular Interventions. Those...

CardiAQ, Edwards, acquire, acquisition, Fortis, TMVI, mitral valve replacement

Edwards Lifesciences Corp. announced that it has agreed to acquire CardiAQ Valve Technologies Inc., a privately held company and developer of a transcatheter mitral valve replacement (TMVR) system...

platelet-like particles, PLPs, clotting, substitute, Carver, Lyon, NIBIB

Researchers have created tiny gel particles that can perform the same essential functions as platelets. The particles could one day be used to control excessive bleeding following traumatic injury...

Opsens Medical, FFR, OptoWire, OptoMonitor, FDA, fractional flow reserve

Opsens Inc. announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the OptoWire and OptoMonitor, its products developed to measure fractional flow reserve (FFR). This...

St. Jude Medical, OCT, ILUMIEN III, IVUS, angiography, PCI

St. Jude Medical, Inc. announced the launch of the ILUMIEN III clinical trial on June 30. ILUMIEN III is a prospective, international, randomized trial evaluating the clinical benefits of the...

Abiomed, U.S. headquarters expansion, Impella 2.5, RP, jobs

During an event with Massachusetts Gov. Charlie Baker in June, Abiomed announced a major expansion of its U.S. headquarters in Danvers, Massachusetts, and the creation of approximately 100 new,...

C.R. Bard, LEVANT 2 results, Lutonix 035 DCB, drug coated balloon, PTA

C.R. Bard Inc. announced the publication of results from the LEVANT 2 study in the June 24, 2015, online issue of The New England Journal of Medicine. Results from LEVANT 2 demonstrated...

Toshiba, CT-angiography, hybrid OR

All of the major vendors in the United States introduced new systems and technologies in the past few years to reduce dose and enhance visualization in the cath lab. The vendors have tailored...

Corvia Medical, IASD, REDUCE LAP-HF, InterAtrial Shunt Device, heart failure

DC Devices Inc. announced that it has completed enrollment and implants in the REDUCE LAP-HF trial, an open label, multi-center, single-arm study of the InterAtrial Shunt Device (IASD). The IASD...