Press Releases

The Centers for Medicare & Medicaid Services (CMS) has determined that clinical sites that wish to participate in the newly announced CREST-2 carotid artery stenting (CAS) registry must receive accreditation. Accreditation for Cardiovascular Excellence (ACE) is a designated organization to provide these reviews. The objective of the CREST-2 Registry is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial. Patients with severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with CAS performed by experienced and skilled interventionists.

On Sept. 24, 2014Heart Hospital of Austin became the first facility in Texas to implant a new miniaturized, wireless monitoring sensor to manage heart failure (HF). The CardioMEMS HF System is the first and only FDA-approved heart failure monitoring device that has been proven to significantly reduce hospital admissions when used by physicians to manage heart failure.

Infraredx, Inc., a medical device company committed to advancing the diagnosis and management of coronary artery disease, today announced that its first-in-class, dual-modality intravascular imaging technology, TVC Imaging System™, and its TVC Insight™ Catheter received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW).

AliveCor, Inc. announced today the launch of the latest version of the AliveECG app, which provides patients with free real-time atrial fibrillation (AF) detection in ECG recordings using its new FDA-cleared algorithm. The new app helps patients and physicians manage existing conditions with intelligent, personalized and easy-to-use new features.

Kaiser Permanente, the nation’s largest integrated health care system, will support the American Heart Association in a broad effort to improve blood pressure control for African-Americans in two U.S. cities over three years. The program will depend upon community-based efforts, as well as doctors and patients, to help decrease the burden of the so called “silent killer,” aiming to create a model that can be replicated in communities across the country.

Boston Scientific Corporation has initiated the REPRISE III clinical trial, a pivotal study to evaluate the safety and effectiveness of the Lotus Valve System in patients with severe aortic stenosis and who are considered to be at either high or extreme risk for surgical valve replacement.  The Lotus Valve System is the first transcatheter aortic valve replacement (TAVR) device that is both fully repositionable and retrievable prior to release. 

Medtronic, Inc. has received CE (Conformité Européenne) Mark for the TYRX(TM) Absorbable Antibacterial Envelope. This innovative mesh envelope covers an implantable cardiac device to help stabilize the device after implantation and reduce surgical-site infections.

GE Healthcare has installed Cath Lab Efficiency Manager at Saint Luke’s Mid America Heart Institute in Kansas City, MO , a new analytical tool that analyzes the performance of an interventional lab providing hospitals with important data they can use to identify areas of improvement.  Cath Lab Efficiency Manager provides a near-real-time dashboard which displays measures of inefficiency and identifies the factors impacting performance. The tool visualizes where changes can be made to help increase productivity and help improve patient care.

Sanofi and MyoKardia, Inc., a privately-held company leading the development of precision therapies for genetic heart disease, announced today a worldwide collaboration to discover and develop first-of-its-kind targeted therapeutics for heritable heart diseases known as cardiomyopathies, the most common forms of heart muscle disease. The collaboration builds upon MyoKardia’s pioneering science, which hopes to correct the disruptive effects that disease mutations have on heart muscle function.

Abbott announced today the start of the ABSORB IV clinical trial, which will test whether its Absorb Bioresorbable Vascular Scaffold (BVS) is more cost-effective and offers a higher quality of life than a best-in-class, permanent, metallic drug eluting stent. Absorb is the world's first drug eluting BVS and functions like a metallic stent by opening up blocked blood vessels in the heart and restoring blood flow. However, unlike a metallic stent, Absorb completely dissolves over time after doing its job. ABSORB IV is designed to enroll approximately 3,000 people with coronary artery disease, mostly in the United States.

Amgen today announced data from the Phase 3 SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study evaluating ivabradine in patients with chronic heart failure (HF) were presented at the 18th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) in Las Vegas.

ACIST Medical Systems, Inc., a Bracco Group company, pioneer and global market leader of advanced imaging modalities for cardiology, showcased the first-ever HDi™ High-Definition Intravascular Ultrasound System in two live cases at the Transcatheter Cardiovascular Therapeutics meeting in Washington, D.C.

InspireMD, Inc., a leader in embolic protection systems (“EPS”), today announced positive results from the CARENET (CARotid Embolic protection study using microNET) Trial for its CGuardTM EPS. This trial demonstrates that the MicroNetTM covered CGuardmay offer important clinical benefits for patients undergoing carotid artery stenting (CAS).

Merge Healthcare Incorporated, a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare, today announced Willis-Knighton Health System, a large non-profit community healthcare organization with four hospitals in the Shreveport and Bossier City, La. area comprising of a 600+ physician network, has selected Merge's enterprise-wide cardiology and interoperability solutions to simplify workflow and advance clinical reporting and analytics. The solution also supports improved documentation for core measures and Meaningful Use (MU) requirements and enables easier access to images, improved patient experience and enhanced business continuity across all Willis-Knighton locations.

Medtronic, Inc. today announced the U.S. launch of the SEEQ Mobile Cardiac Telemetry (MCT) System, an external, wire-free, adhesive heart monitor that can be worn for up to 30 days to help detect and diagnose the cause of irregular heartbeats in patients.  Medtronic completed the acquisition of U.S.-based Corventis, Inc., which developed the technology, in June 2014.

Cardiac Dimensions, Inc. today announced that new long-term outcomes data from the TITAN II clinical trial of its enhanced CARILLON Mitral Contour System showed significant and sustained improvements in mitral regurgitation, functional improvement, quality of life and reverse cardiac remodeling. The long-term safety and efficacy data, which was consistent with previous trials of the system, was presented Sept. 13 at the 26th annual Transcatheter Cardiovascular Therapeutics Conference (TCT) in Washington, DC by TITAN II investigator Professor Dr. Michael Haude of Lukaskrankenhaus in Neuss, Germany.

Cardioxyl Pharmaceuticals, Inc. announced today that its experimental heart failure compound has been shown to be effective in animal models following oral (capsule) dosing. The preclinical results demonstrate an alternative to intravenous infusions that could pave the way for convenient outpatient therapy with HNO prodrugs. The data were presented yesterday at the Heart Failure Society of America’s (HFSA) 18th Annual Scientific Meeting in Las Vegas.

The Society for Cardiovascular Angiography and Interventions (SCAI) has named Lisa Olson, PhD, as its new executive director. Olson brings deep experience and expertise in the cardiovascular field and a vision for continuing to advance SCAI’s mission.

Amaranth Medical, a privately held medical device company, announced the initiation of patient enrollment in multiple centers in Colombia, South America in MEND-II, a clinical trial to assess safety and feasibility of the Company's FORTITUDE(R) Sirolimus-Eluting Bioresorbable Scaffold in patients with symptomatic coronary artery disease. As seen with the first generation scaffold, preliminary patient results using optical coherence tomography (OCT) following implantation show that the scaffolds were fully apposed to the vessel wall achieving optimal acute lumen gain.

Presented for the first time at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) conference, the latest clinical and economic data on the IN.PACT Admiral drug-coated balloon (DCB) from Medtronic, Inc. augments an already robust body of evidence that continues to drive a reconsideration of the standard of care for peripheral artery disease (PAD) in leg arteries above the knee.

New data from the Boston Scientific clinical trial program of the Lotus Valve System continue to demonstrate strong performance as a less invasive treatment for patients with severe aortic stenosis who are considered high risk for surgical valve replacement.