Technology

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

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

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

The ViperWire Advance Peripheral Guide Wire with Flex Tip from Cardiovascular Systems Inc. is indicated for use with their peripheral orbital atherectomy systems (OAS)....

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

The Protégé GPS self-expanding peripheral stent system from Medtronic is indicated for the treatment of stenotic lesions of the common and external iliac arteries. 

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

The OptoWire and OptoMonitor products from Opsens Inc. measure fractional flow reserve (FFR)....

Medtronic, CoreValve Evolut R, FDA approval, TAVR, recapturable

The recapturable, self-expanding CoreValve Evolut R System from Medtronic is approved for transcatheter aortic valve replacement (TAVR) in severe aortic stenosis patients who are at high or extreme...

cangrelor, Kangreal, FDA approval, The Medicines Company, antiplatelet agent

Cangrelor (Kengreal) from The Medicines Company is a novel intravenous antiplatelet agent indicated as an adjunctive therapy to percutaneous coronary intervention (PCI)....

Edwards, Sapien 3, FDA approval, transcatheter heart valve

The Edwards Sapien 3 valve with the Commander Delivery System is indicated for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis....

Penumbra, ACE64, aspiration thrombectomy, acute ischemic stroke, FDA

The ACE64 aspiration thrombectomy system from Penumbra Inc. is indicated for the revascularization of large vessel occlusions in patients with acute ischemic stroke.

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Merit Medical, Prelude Snap, splittable sheath introducer

The Prelude Snap splittable sheath introducer is easier to break, approximately 33 percent easier than competitors. An easier-to-break sheath can minimize harsh movements of the lead during re...

enroute carotid stent

The Enroute transcarotid neuroprotection system (NPS) from Silk Road Medical Inc....

Medtronic, Euphora, SC, semicompliant balloon dilatation catheter, FDA, U.S.

The Euphora Semicompliant Balloon Dilatation Catheter is a pre-dilatation therapy used during a stent implantation to reopen a narrowed coronary artery caused by plaque buildup.

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CSI, Diamondback 360, atherectomy, PAD, Stealth 360

Cardiovascular Systems Inc. announced that it has received U.S....

Corevalve, VIV, valve in valve, FDA

The CoreValve self-expanding transcatheter aortic valve repla...

ticagrelor, AstraZeneca, FDA, crushing, option

Ticagrelor (Brilinta) 90 mg tablets from AstraZeneca now have FDA approval to be crushed and administered in water by swallowing or via nasogastric tube.

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Toshiba, CT angiography, Infinix 4D CT

The Toshiba Infinix 4D CT system enables computed tomography (CT) imaging directly in the cath lab....

Impella, FDA, high risk PCI, abiomed

Abiomed’s Impella 2.5 heart pump has gained an additional FDA...

Boston Scientific, Watchman LAA device, FDA approval

The Watchman left atrial appendage closure device from Boston Scientific Corp....

VenaSeal, varicose veins, Covidien, FDA

The VenaSeal closure system is designed to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.

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Radiance Ultra, NDS Surgical Imaging, flat panel displays, hybrid OR

The 27-inch Radiance Ultra is a next-generation surgical visualization platform from NDS Surgical Imaging....

ResQCPR System, resuscitation devices, cardiac arrest, CPR, FDA

The ResQCPR System from Zoll Medical Corp. is a system of two devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on cardiac arrest patients....

CompView Medical, NuCart, mounts, flat panel displays, hybrid OR, mobile boom

The NuCart from CompView Medical is an all-in-one equipment manager, visualization and ergonomic boom system....

Pie Medical Imaging, CAAS A-Valve, qRA, angiography, heart valve repair

The CAAS A-Valve from Pie Medical Imaging BV is the first 510(k)-cleared image analysis technology to determine aortic regurgitation based on X-ray angiography....

Balloon catheters, Heart Valve repair, Cath Lab, Hybrid OR

January 28, 2015 — Maquet Medical Systems USA announced an agreement to serve as the exclusive U.S. distributor of InterValve Inc.'s V8 Aortic Valvuloplasty Balloon Catheter....