Heartwire

Alert FDA OKs Sapien 3 for Mitral, Aortic Valve-in-Valve Replacement Limited to high-surgical-risk patients, the expanded indication marks the first approval of any transcatheter valve for treatment of failed mitral and aortic bioprostheses, says the agency.
News, June 05, 2017
Alert FDA Clears Medtronic's Resolute Onyx Drug-Eluting Stent With the first 4.5-mm and 5.0-mm drug-eluting stent sizes available in the US, the stent expands treatment options for patients with large coronary anatomies.
News, May 01, 2017
Alert FDA Approves Medtronic CoreValve Evolut PRO The device, based on the CoreValve Evolut R platform, features modifications meant to address paravalvular leakage.
News, March 22, 2017
FDA Clears CardioInsight 3D Mapping System for Arrhythmias "We are effectively streamlining the clinical procedure planning process for clinicians and making it easy for patients to receive precise mapping results from their providers right at their bedside," claim proponents.
News, February 01, 2017
Alert FDA Approves Shockwave's Lithoplasty System for PAD The newly FDA-approved Lithoplasty System combines two technologies to target hardened arterial calcium in patients with PAD.
News, September 16, 2016
Alert Medtronic Gets FDA Nod on Drug-Coated Balloon for ISR in PAD For the first time, the agency has approved a drug-coated balloon, the IN.PACT Admiral, to treat in-stent restenosis in peripheral artery disease.
News, September 14, 2016
Alert FDA Approves Once-Monthly Evolocumab (Repatha) Device A new device that provides a single monthly injection of the cholesterol drug has been approved and should be available in the US next month.
News, July 11, 2016
Alert FDA Approves Abbott's Bioresorbable Stent for CAD The device "offers a new treatment option for individuals who are candidates for angioplasty but would prefer an absorbable device rather than a permanent metallic coronary stent," said the FDA.
News, July 05, 2016
Alert FDA Approves Generic Rosuvastatin (Crestor) Rosuvastatin goes off patent and presumably plunges in price, at a time when clinicians overall have been lukewarm about prescribing the comparatively expensive, recently approved PCSK9 inhibitors.
News, April 29, 2016
FDA Approves Impella Heart Pumps for Cardiogenic Shock The entire family of Impella left side heart pumps has been approved for cardiogenic shock.
News, April 08, 2016
Alert FDA Approves Micra, First Leadless Pacemaker for US Patients The approval comes almost 2 months after an advisory panel met to work out the technology's practice implications. Both the Micra and Nanostim devices are already available in Europe.
News, April 06, 2016
Alert FDA Approves Oral Potassium-Binder Patiromer (Veltassa) It's been shown in trials to safely normalize serum potassium levels in patients taking drugs known to raise potassium, including aldosterone blockers and ACE inhibitors.
News, October 21, 2015
Alert TCT FDA Approves Sapien XT for Valve-in-Valve TAVR "No patient with a failed surgical valve should have to go through another operation when you can have such good results in valve-in-valve," said an expert impressed by reported 1-year results.
News, October 15, 2015
Alert FDA Approves DES With Bioabsorbable Polymer (Synergy) The stent polymer is fully absorbed after 3 months, leaving behind a bare platinum-chromium stent. By eliminating the polymer, the hope is the stent will promote speedier healing and reduce the risk of vascular complications.
News, October 05, 2015
Alert FDA Approves First ICD Designed to Be MRI Compatible (Evera MRI ICD) The device, which is a single- or dual-chamber ICD modified with changes to the firmware and hardware to make it compatible with an MRI scan, is the first device of its kind to be approved for use in the US.
News, September 14, 2015
Alert FDA Green-lights Evolocumab (Repatha) for LDL-Cholesterol Lowering There are now two PCSK9 inhibitors available to US physicians, with the FDA approving evolocumab one month after alirocumab. The indications for both drugs are similar, with neither approved for statin-intolerant patients.
News, August 25, 2015
Alert FDA Approves Valsartan/Sacubitril (Entresto) for Heart Failure Its approval having bypassed the advisory-panel step and after impressing most observers in a major randomized trial, the novel agent is seen as something of a landmark in chronic heart-failure therapy.
News, July 07, 2015
Alert FDA Approves Cangrelor (Kengreal) for PCI The approval in the PCI setting is based on data from CHAMPION-PHOENIX, where cangrelor reduced the risk of thrombotic events compared with patients treated clopidogrel.
News, June 22, 2015
Alert FDA Approves Sapien 3 Transcatheter Heart Valve The third-generation device is an upgrade over the older Sapien valves in that it adds an outer skirt to minimize the risk of paravalvular leak. It also has a lower frame height, improved frame geometry, and a low delivery profile.
News, June 18, 2015
Alert CoreValve Approved for Valve-in-Valve Replacement CoreValve is the first transcatheter valve approved in the US for patients who need an aortic valve replaced but who are at a high/extreme risk for complications with surgery.
News, March 31, 2015

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