Coronary/Structural Heart

Shockwave IVL Meets Safety and Effectiveness Endpoints in U.S. Coronary Pivotal IDE Study

Positive Disrupt CAD III Data Submitted to FDA in Premarket Approval Application SANTA CLARA, Calif., Oct. 15, 2020 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the coronary Investigational Device […]

DEFINE PCI study one-year data show potential of treating residual ischemia to improve clinical outcomes for coronary stent patients

October 15, 2020 New data suggest that PCI guided by iFR co-registered on the angiogram can improve outcomes and reduce angina for patients more effectively than treatment guided by angiography alone Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the one-year results […]

CSRC Spearheads Creation of First National Pediatric Cardiac Screening Database

FDA, industry, and patient advocacy groups join effort to advance effective cardiac screening DURHAM, N.C.–(BUSINESS WIRE)–The Cardiac Safety Research Consortium (CSRC) announces the establishment of a first-in-kind national database of pediatric cardiac screening information aimed at advancing the ability to discover potentially dangerous pediatric cardiac conditions and preventing sudden cardiac […]

Spring Hills Launches End-to-End Cardiac Program to Help Patients Transition from Hospital to Home

Bold New Program Enhances Patient Care While Decreasing Costly Hospital Readmissions and Gaps in Care EDISON, N.J.–(BUSINESS WIRE)–Spring Hills today announced that it has launched a new comprehensive cardiac program at three of its post-acute care facilities in New Jersey. Currently accepting patients in Livingston, Wayne and Woodbury, the program features […]

Largest Study of Hemodynamically Supported High-Risk PCI Patients Finds More Complete Revascularization with Impella Leads to Improved Outcomes

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces new PROTECT III study data that demonstrates reduced rates of MACCE (composite of death, stroke, myocardial infarction and repeat procedures) when Impella is used to achieve a more complete revascularization in a single setting for high-risk percutaneous coronary intervention (PCI) patients. PROTECT III is an ongoing, prospective, […]

Tenax Therapeutics Gains North American Rights to Oral Levosimendan through Expanded License Agreement with Orion Corporation

Tenax gains developmental and commercial rights for a fully-developed oral levosimendan formulation in the U.S. and Canada Oral formulation expected to be used in upcoming Phase 3 registration trial MORRISVILLE, N.C.–(BUSINESS WIRE)–Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products for the critical […]

Medtronic Launches Head-to-Head TAVR Study Comparing the Evolut™ TAVR Platform Against the Edwards SAPIEN Valve in Small Annulus Patients

Medtronic Also Begins Feasibility Study of Evolut TAVR System in Moderate and Asymptomatic Aortic Stenosis Patients DUBLIN, Oct. 14, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in structural heart therapies, today announced it will begin a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic […]

Results of the PROSPECT II Natural History Study Demonstrate High-Risk Plaques Identified by NIRS+IVUS Imaging are Linked to Future Coronary Events

PROSPECT ABSORB, a randomized substudy, showed treatment of high risk plaques with BVS is safe and associated with favorable long-term clinical outcomes compared to GDMT alone BEDFORD, Mass.–(BUSINESS WIRE)–Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced positive results from the PROSPECT II and […]

Medtronic Announces Partnership with The Foundry to Develop Innovative Mitral Valve Repair Technology

Half Moon Medical’s Technology Now Ready for Evaluation in Early Feasibility Study DUBLIN, Oct. 14, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced a partnership with The Foundry – a medical device company incubator – dating back to mid-2017 to invest in and create a company with the […]

Restore EF Study Demonstrates Impella-Supported High-Risk PCI Improves Left Ventricular Ejection Fraction

DANVERS, Mass.–(BUSINESS WIRE)–The Restore EF Study demonstrates the use of contemporary best practices, including attempting a more complete revascularization with Impella-supported high-risk PCI, is associated with significant improvement of left ventricular ejection fraction (LVEF), heart failure symptoms, and anginal symptoms at follow up. The interim analysis was presented today by Mitul […]