Coronary/Structural Heart

Conformal Medical’s CLAAS® Stroke Prevention Technology Announces Promising Clinical Results at 2020 TCT Conference

U.S. and European feasibility studies demonstrate early success of novel conformable foam matrix implant for LAAC NASHUA, N.H., Oct. 15, 2020 /PRNewswire/ — Conformal Medical, Inc., a privately held medical device company developing next generation left atrial appendage closure (LAAC) technology, today announced positive clinical data from First-in-Human studies performed in the U.S. and Prague.  […]

Bracco Diagnostics Inc. Introduces New CardioGen-82® (Rubidium Rb 82 Generator) Infusion System

MONROE TOWNSHIP, N.J., Oct. 16, 2020 /PRNewswire/ — Bracco Diagnostics Inc., the U.S subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, announced today the FDA approval of its new CardioGen-82 infusion system to enhance automation, efficiency and simplicity in cardiac position emission tomography (PET) myocardial perfusion imaging (MPI). […]

VASCEPA® (Icosapent Ethyl) Found to Significantly Reduce Ischemic Events in Patients with Prior Percutaneous Coronary Intervention (PCI) in Post Hoc Subgroup Analyses of Landmark REDUCE-IT® Study Presented at Transcatheter Cardiovascular Therapeutics (TCT) Connect 2020

VASCEPA®, compared with placebo, significantly reduced primary composite first and total MACE (major adverse cardiovascular events) in post hoc exploratory analyses of patients with a history of PCI by 34% and 39%, respectively, and key secondary composite first hard MACE, comprised of heart attacks, stroke and cardiovascular death, by 34% Administration of VASCEPA resulted in robust absolute risk reductions of 8.5% and 5.4% and numbers needed to treat (NNT) of 12 and 19, respectively, for both […]

Novartis receives positive CHMP opinion for Leqvio®* (inclisiran), a potential first-in-class siRNA for the treatment of high cholesterol

If approved, inclisiran will be the first and only small interfering RNA (siRNA) in Europe for patients with hypercholesterolemia or mixed dyslipidemia1 Cardiovascular disease (CVD) claims 3.9 million lives annually in Europe2, and 80% of high-risk patients do not reach guideline-recommended low-density lipoprotein cholesterol (LDL-C) targets despite the widespread use of statins3–5 Inclisiran provides effective and sustained reduction of LDL-C of up to […]

New Data Highlight a Significant Increase in Cardiovascular Treatment Efficiency when the HeartFlow Analysis is Incorporated into the Diagnostic Pathway

Nine-month results from FORECAST trial show statistically significant reduction in unnecessary invasive cardiac testing, increase in catheterization lab efficiency, and reduction in repeat non-invasive testing REDWOOD CITY, Calif.–(BUSINESS WIRE)–Late-breaking results presented today confirm that incorporating the HeartFlow® FFRct Analysis into a coronary computed tomography angiogram (CTA)-led diagnostic pathway significantly increases overall […]

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, […]