Press Releases

In a major symposium at the American Association for Cancer Research (AACR) Annual Meeting 2015, University of Colorado Cancer Center investigator Tim Byers, MD, MPH, describes research showing the link between cancer, diabetes and cardiovascular disease.

Medtronic plc (NYSE: MDT) today announced it has received CE (Conformité Européenne) Mark of the Micra® Transcatheter Pacing System (TPS), the world’s smallest pacemaker. At less than one-tenth the size of traditional pacemakers, the Micra device provides the most advanced pacing technology available while being cosmetically invisible and small enough to be delivered with minimally invasive techniques through a catheter, and implanted directly into the heart.

Medtronic plc today announced the first patient enrollment in the GOLD AF Registry, a first-of-its-kind, prospective, observational clinical study of its Phased Radiofrequency (RF) Ablation technology for treating patients with symptomatic atrial fibrillation (AF). The multicenter registry will provide real-world insights into the procedural use and treatment outcomes of the Pulmonary Vein Ablation Catheter® (PVAC) GOLD, multi-electrode ablation catheter and other catheters that comprise Medtronic's Phased RF technology.

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) filed a supplemental New Drug Application (sNDA) for Pradaxa® (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery. If approved, this will become the fourth indication for PRADAXA.

Medtronic plc today announced its acquisition of Diabeter, an innovative, independent Netherlands-based diabetes clinic and research center dedicated to providing comprehensive and individualized care for children and young adults with diabetes.

Sanford-Burnham Medical Research Institute (Sanford-Burnham) today announced that it has signed a licensing agreement to further develop a first-in-class small molecule with Daiichi Sankyo for the treatment of cardiovascular-metabolic disease. The small molecule is based on longstanding, groundbreaking biology work by a Sanford-Burnham scientist and his laboratory team, who for decades focused their research on treating a consequence of cardiovascular-metabolic disease.

Dr. Daniel Melby, an investigator at the Minneapolis Heart Institute Foundation (MHIF), performed the first atrial fibrillation ablation in the U.S. using Biosense Webster’s new THERMOCOOL SMARTTOUCH SF contact force sensing catheter as part of an FDA regulated safety trial (SMART-SF). Biosense Webster is part of the Johnson & Johnson family of companies. “The SMARTTOUCH SF catheter is an important evolution in RF ablation technology,” said Dr. Melby. “Contact force sensing combined with the more efficient irrigation design of this catheter may allow for a more effective ablation pattern while potentially reducing risk of thrombus formation and improving outcomes.” 

Bayer HealthCare (Bayer) has expanded its collaboration with the Broad Institute of Massachusetts Institute of Technology (MIT) and Harvard University to include cardiovascular genomics and drug discovery. The goal of this new part of the alliance is to leverage insights from human genetics to help create new cardiovascular therapies.

Medtronic plc (NYSE:MDT) today announced the initiation of the SPYRAL HTN Global Clinical Trial Program, a unique, phased clinical program studying renal denervation in uncontrolled hypertension. This announcement follows investigational device exemption (IDE) approval by the U.S. Food and Drug Administration (FDA). The program will begin with two global studies designed to address the confounding factors encountered in the SYMPLICITY HTN-3 clinical trial, including medication, patient population and procedural variability, to ensure the clinical potential of the therapy is evaluated.

SynCardia Systems, Inc. has received FDA approval to conduct an Investigational Device Exemption (IDE) clinical study on the effective use of its 50cc SynCardia temporary Total Artificial Heart.

A team of investigators at Children’s Hospital Los Angeles and the University of Southern California have developed the first fully implantable micropacemaker designed for use in a fetus with complete heart block. The team has done preclinical testing and optimization as reported in a recent issue of the journal Heart Rhythm. The micropacemaker has been designated a Humanitarian Use Device by the US Food & Drug Administration (FDA). The investigators anticipate the first human use of the device in the near future.

Qualcomm Life, Inc., a subsidiary of Qualcomm Incorporated (NASDAQ: QCOM), and AMC Health, a privately held provider of ‘real-time’ patient management solutions, today announced a collaborative effort to accelerate the transformation of chronic care and population health management by significantly enhancing connectivity and care coordination for at-risk patients, specifically those with heart failure, hypertension, diabetes, asthma or COPD, in a cost-effective manner. The companies will integrate Qualcomm Life’s 2net™ Connectivity Platform with AMC Health’s CareConsole care coordination platform.

The National Institutes of Health has selected three new proof-of-concept hubs to help speed the translation of basic biomedical discoveries into commercial products, such as new drugs, devices, and diagnostics, to improve patient care and enhance health. The hubs are part of the NIH-supported Research Evaluation and Commercialization Hubs (REACH) program and will be funded at $9 million over three years.

It's been nearly a decade since Gheorghe Sandru received the heart implant that changed his life.

Dignity Health Sequoia Hospital’s Heart and Vascular Institute announced today it has entered into an affiliation with the world-renowned Cleveland Clinic Sydell and Arnold Miller Family Heart & Vascular Institute. This affiliation is the first of its kind in Northern California.

The American College of Cardiology today elected Kim Allan Williams, M.D., FACC, as president for the upcoming year at its 64th Annual Scientific Sessions.

St. Jude Medical, Inc., a global medical device company, today announced a new data analysis from the CHAMPION trial showing that heart failure (HF) patients with reduced ejection fraction on optimal doses of guideline directed medical therapy (GDMT) managed by pulmonary artery (PA) pressure monitoring with the CardioMEMS™ HF System had a 57 percent reduction in mortality and a 43 percent reduction in HF hospitalizations compared with patients on GDMT managed by the standard of care (SOC). These data show a strong improvement for patients managed by optimal GDMT and the CardioMEMS HF System in both mortality and hospitalizations over currently defined best practices.

Medtronic plc today announced initial clinical outcomes for its next-generation CoreValve Evolut R System. At 30-days, the new recapturable, self-expanding valve showed no incidents of all-cause mortality or stroke in a high and extreme risk patient population.  Data from the Evolut R Study, which enrolled 60 patients from six centers in the United Kingdom, Australia and New Zealand, were unveiled today at the 64th Annual Scientific Session of the American College of Cardiology (ACC.15). The CoreValve Evolut R System is not approved for commercial use in the United States where it is currently undergoing clinical trials.

Merck, known as MSD outside the United States and Canada, today announced results from a pre-specified exploratory analysis of the investigational IMPROVE-IT study of more than 18,000 patients presenting with acute coronary syndromes. The new analysis shows that VYTORIN® (ezetimibe/simvastatin) – which combines simvastatin with the non-statin ZETIA® (ezetimibe) – reduced total (defined as initial and recurrent) cardiovascular events by 9% compared to simvastatin alone (incidence-rate ratio [IRR] 0.91, 95% CI 0.85-0.97, p=0.007; by treatment group, 4,562 vs. 4,983 total events, respectively). These data were presented as part of this afternoon’s late-breaking featured clinical research session at the 2015 American College of Cardiology Scientific Sessions.

Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that 30-day outcomes for high- and intermediate-risk patients treated with the SAPIEN 3 transcatheter aortic valve demonstrated the lowest all-cause mortality rates of any of the PARTNER studies, as well as excellent clinical outcomes on the other components of the primary endpoint measures of stroke and paravalvular regurgitation.  This first report of SAPIEN 3 data in the United States, and first report on intermediate risk transcatheter aortic valve replacement (TAVR) patients, was presented as part of the late-breaking clinical trials at the American College of Cardiology's (ACC) 64th Annual Scientific Session in San Diego.

Full results from a Phase 3 study examining Portola Pharmaceutical's developmental compound andexanet alfa found it rapidly and significantly reversed the blood thinning (anticoagulant) effects of XARELTO (rivaroxaban). These results, from the first part of the ANNEXA-R (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXa Inhibitors – Rivaroxaban) study, will be presented at the 64th Annual Scientific Session of the American College of Cardiology (ACC) on March 16, 2015. Additional findings to be presented at the meeting include new 24-month results from an ongoing, five-year, observational study of people with non-valvular atrial fibrillation taking XARELTO, which showed the rates and patterns of major bleeding in routine clinical practice were generally consistent with those observed in Phase 3 clinical trials used to approve the medicine for this indication.