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Press Releases

DUBLIN — November 20, 2017 — Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval and U.S. commercial launch for its portfolio of Azure(TM) pacemakers with BlueSync(TM)technology.

A new real-world analysis of adults with type 2 diabetes and established cardiovascular disease (CVD) shows adult patients who initiated therapy with INVOKANA® (canagliflozin) or another sodium glucose cotransporter-2 inhibitor (SGLT2i) had a 43 percent reduced risk for all-cause mortality (ACM) and hospitalization for heart failure (HHF) after an average of 1.6 years, compared to similar patients who initiated treatment with a non-SGLT2i medication using an intent-to-treat (ITT) approach.

SILVER SPRING, Md., Nov. 16, 2017 — The U.S. Food and Drug Administration today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.

RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 13, 2017 — New data presented today showed that Jardiance® reduced the risk of cardiovascular death compared with placebo when added to standard of care in adults with type 2 diabetes and peripheral artery disease. 

THOUSAND OAKS, Calif., Nov. 13, 2017 — Amgen (NASDAQ:AMGN) today announced five new subgroup analyses from the Repatha® (evolocumab) cardiovascular outcomes study (FOURIER) that showed the addition of Repatha to statin therapy improved clinical outcomes with significant reduction of cardiovascular (CV) events, such as heart attack (also called myocardial infarction or MI) and stroke, in high-risk patients with peripheral artery disease (PAD), and in patients with a history of heart attack.

The Centers for Medicare & Medicaid Services (CMS) today finalized its rule for the Merit-Based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs) that AMGA contends will slow the transition to value.

Medtronic plc (NYSE:MDT) announces the release of its fiscal year 2017 Integrated Performance Report. The report highlights the combined financial, social, and environmental impact of Medtronic.

DUBLIN and DENVER - November 2, 2017 - Medtronic plc (NYSE:MDT) today presented new data at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting showcasing the excellent clinical performance of the Evolut(TM) Transcatheter Aortic Valve Replacement (TAVR) platform.

Medtronic plc (NYSE:MDT) today presented new clinical research to support the positive clinical performance of the Evolut™ Transcatheter Aortic Valve Replacement (TAVR) Platform in intermediate-risk, severe, symptomatic, aortic stenosis patients. Outcomes from the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) Trial and the Evolut R FORWARD “real-world” study were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting, reinforcing the valve’s strong performance in healthier, more active patients.

Abbott today announced it received CE Mark for XIENCE Sierra, the newest generation of the company’s gold-standard XIENCE everolimus-eluting coronary stent system.

Cordis is Now the Exclusive U.S. Distributor of Medinol Coronary Stents

SAN CLEMENTE, Calif., Oct. 26, 2017 — ROX Medical Inc., a privately held medical device company pioneering an innovative interventional vascular therapy for uncontrolled hypertension, announced the publication of 12-month outcomes of the ROX CONTROL HTN study in the prestigious journal, Hypertension.

DANVERS, Mass., Oct. 26, 2017 — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, announced today the first patient treated with the Impella heart pump in Japan. The Impella 2.5® and Impella 5.0® heart pumps are approved for the treatment of drug-resistant acute heart failure and are the first and only percutaneous temporary ventricular support devices Pharmaceuticals and Medical Devices Agency (PMDA) approved in Japan.

Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today reported financial results for the quarter ended September 30, 2017. 

Medtronic plc (NYSE:MDT) today announced the first patient implant in the APOLLO Trial — the pivotal trial designed to evaluate the Intrepid(TM) TMVR system following receipt of an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA).

CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using CytoSorb® blood purification to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, highlights the largest endocarditis valve replacement study using CytoSorb published to date entitled, "Hemoadsorption treatment of patients with acute infective endocarditis during surgery with cardiopulmonary bypass – a case series".

GLEN MILLS, Pa., Oct. 17, 2017 — Unequal®, a leading manufacturer of sports protective gear, announced that the Food and Drug Administration has determined that Unequal's patented HART® CC Pad device, found in every Unequal HART chest protector, can improve safety on the playing field.

NEW YORK, October 4, 2017 — Peerbridge Health Inc., a Health IT company, announced today that its first product, The Peerbridge Cor™ System—a wireless electrocardiogram (ECG) monitor—has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

DUBLIN — October 9, 2017 — Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the Endurant(TM) II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients with neck lengths down to 4mm and <=60° infra-renal angulation when used in combination with the Heli-FX(TM) EndoAnchor(TM) system.

SAN CLEMENTE, Calif., Oct. 4, 2017 — ROX Medical, Inc., a privately held medical device company pioneering an innovative interventional vascular therapy for Uncontrolled Hypertension, announced today that the first patient was treated in the CONTROL HyperTeNsion (HTN)-2 clinical study, the Company's pivotal study to evaluate the safety and effectiveness of the ROX Coupler used to create an arterio-venous anastomosis in the iliac vessels, in patients with high blood pressure.