Tag: Spectranetics

FDA Classifies Spectranetics’ Bridge Occlusion Balloon as Class I Recall

Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall – Risk of Blocked Guidewire Lumen Preventing Balloon Utilization ISSUE: Spectranetics is recalling its Bridge Occlusion Balloon Catheter due to the possibility of a blocked guidewire lumen in some device units. If a device with a blocked guidewire lumen […]

Efficacy Of Royal Philips Electronics N.V. (PHG)’ Stellarex .035″ Low-Dose Drug-Coated Balloon Demonstrated In Clinical Trial At Two Years

AMSTERDAM and LAS VEGAS, Sept. 14, 2017 /PRNewswire/ — Royal Philips (NYSE: PHG; AEX: PHIA), a global leader in health technology, announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating the efficacy of Philips Spectranetics’ Stellarex .035″ drug-coated balloon (DCB) for peripheral arterial disease (PAD) in comparison to uncoated balloon angioplasty. Marianne […]

Spectranetics Recalls Bridge Occlusion Balloons

Philips subsidiary Spectranetics recalls Bridge occlusion balloon AUGUST 31, 2017 BY BRAD PERRIELLO , MassDevice Royal Philips (NYSE:PHG) subsidiary Spectranetics recalled its Bridge occlusion balloon after receiving reports of blocked guidewire lumens. The Bridge device is used to temporarily block the superior vena cava for emergency control of hemorrhage. Spectranetics said the August 25 recall was […]

Spectranetics Announces Fundamental Change, Make-Whole Adjustment Event, Share Exchange Event and Supplemental Indenture for 2.625% Convertible Senior Notes due 2034

COLORADO SPRINGS, Colo., Aug. 10, 2017 (GLOBE NEWSWIRE) — The Spectranetics Corporation (NASDAQ:SPNC) (“the Company”), a developer and manufacturer of single-use medical devices used in minimally invasive procedures within the cardiovascular system, today announced the occurrence of a Fundamental Change, Make-Whole Adjustment Event and Share Exchange Event, and the execution […]

Philips completes acquisition of The Spectranetics Corporation

Amsterdam, the Netherlands and Colorado Springs, CO, U.S. – Royal Philips (NYSE: PHG; AEX: PHIA), a global leader in health technology, today announced that it has completed the acquisition of The Spectranetics Corporation (NASDAQ: SPNC), a U.S.-based global leader in vascular intervention and lead management solutions. Spectranetics’ financial results will be consolidated as part of […]

Spectranetics (SPNC) Secures FDA Approval of Stellarex Drug-Coated Balloon

COLORADO SPRINGS, Colo., July 26, 2017 (GLOBE NEWSWIRE) — The Spectranetics Corporation (NASDAQ:SPNC) today announced receipt of U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) of the Stellarex™ drug-coated balloon (DCB), designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease […]

Royal Philips Electronics N.V. (PHG) Slams Down $2.16 Billion for Spectranetics (SPNC)

6/28/2017 5:53:44 AM  Philips To Acquire The Spectranetics Corporation To Accelerate Expansion In Image-Guided Therapy Devices To Treat Cardiac And Peripheral Vascular Disease  AMSTERDAM, the Netherlands and COLORADO SPRINGS, Colo., June 28, 2017 (GLOBE NEWSWIRE) — Royal Philips(NYSE:PHG) (AEX:PHIA), a global leader in health technology, and The Spectranetics Corporation (NASDAQ:SPNC), a U.S.-based global […]