Coronary/Structural Heart

First Patient Enrolled in REAL SSO2 Study to Evaluate Clinical Utility and Economic Value of ZOLL TherOx SSO2 Therapy

CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL, an Asahi Kasei company, announced today that the first patient has enrolled in the REAL SSO2 post-market observational study to assess the clinical utility and cost-effectiveness of TherOx SuperSaturated Oxygen (SSO2) Therapy compared to PCI alone in standard of care treatment for ST-elevation myocardial infarction (STEMI) patients. The […]

NewAmsterdam Announces Positive Results from ROSE2, Phase 2 Trial Evaluating Obicetrapib in Combination with Ezetimibe as an Adjunct to High-Intensity Statin Therapy

— Achieved primary endpoint with statistically significant reduction in LDL-C (p < 0.0001) — — Median percent change in LDL-C of -59% in combination arm compared to -6% in placebo arm — — Favorable safety and tolerability — — Data support advancement of fixed-dose combination into bioequivalence and Phase 3 […]

Aitia and G3 Therapeutics Publish Results Identifying New Causal Biomarkers of Atherosclerotic Coronary Artery Disease (ASCAD), the Leading Cause of Morbidity and Mortality Worldwide

Triglyceride-rich LDL particles were found to be directly causal in ASCAD based on Aitia’s Digital Twins built on G3’s Global Multi-omic Clinical Study Data and Aitia’s Causal AI Technology LDL-Triglycerides may become an important diagnostic biomarker in ASCAD and may lead to new therapeutics ATLANTA and SOMERVILLE, Mass., Jan. 12, 2023 /PRNewswire/ — G3 […]

Novel Partnership Between MultiCare’s Pulse Heart Institute and DispatchHealth Produces Unprecedented Success in Lowering Hospital Re-Admission Rates for Chronic Heart Failure Patients

Timely Home-Based Treatment Creates Pathway to Reduce the National 25% Average for Hospital Re-Admissions Down to Just 6.8% SPOKANE, Wash. and DENVER, Jan. 12, 2023 /PRNewswire/ — Known for a solid commitment to advancing heart and vascular medicine in the Pacific Northwest, MultiCare’s Pulse Heart Institute set out to change the narrative for congestive heart failure patients […]

FEops Appoints Euan S. Thomson, PhD as Board Chair in Support of Expanding Digital Health Goals

GENT, Belgium–(BUSINESS WIRE)–FEops announces Euan S. Thomson, PhD has been appointed as new Chairman. Euan Thomson succeeds veteran medical device executive Rob Michiels, who continues to support FEops as an independent board member. FEops has made significant progress with rollout of their HEARTguide structural heart planning software based on digital twin […]

Solid Biosciences and Phlox Therapeutics Announce Strategic Research Collaboration Focused on Accelerating the Development of New Therapies for Rare Cardiac Diseases

Research collaboration to target severe form of genetic dilated cardiomyopathy Collaboration strengthens Solid Biosciences’ scientific capabilities and commercial potential in cardiac therapy Collaboration allows Phlox Therapeutics to leverage Solid Biosciences’ vector biology and manufacturing capacities to deliver its RNA therapies to the heart CHARLESTOWN, Mass. and NAARDEN, The Netherlands, Jan. […]

MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE approval, its fourth FDA IDE DEB Approval

GENEVA, Jan. 10, 2023 /PRNewswire/ — SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of coronary de novo lesions. This comes less than eight months after the company received its first IDE approval for SELUTION SLR in the treatment […]

Prevencio Announces National Medicare Pricing for Company’s Three AI-Powered HART® Cardiac Blood Tests

Newly Assigned Rates Further Validate Commercial Value of the HART Tests KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc., The AI-Powered Cardiac Blood Test Company, today announced the Centers for Medicare & Medicaid Services (CMS) has set a National Medicare payment rate of $390.75 for each of the Company’s three lead proprietary HART® cardiac blood tests. […]

Rocket Pharmaceuticals Expands Cardiac Gene Therapy Portfolio with Addition of RP-A601 for PKP2-ACM and Announces Positive Updated Phase 1 Data for RP-A501 in Danon Disease

RP-A601 for Arrhythmogenic Cardiomyopathy due to PKP2 pathogenic variants (PKP2-ACM) represents meaningful commercial opportunity with estimated prevalence of 50,000 adults and children in the U.S. and EU; IND filing anticipated in Q2 2023 In support of Phase 2 pivotal study, latest positive Phase 1 data in Danon Disease recently shared […]

New Study Evaluates the Performance of Masimo SpHb® Noninvasive Spot-Check Hemoglobin in the Emergency Department

Masimo SpHb on the Handheld Masimo Rad-67® Demonstrated “Acceptable Accuracy and Excellent Correlation” with Laboratory Hemoglobin NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) today announced the results of a prospective study published in the American Journal of Emergency Medicine in which Dr. Zohair Ahmed Ali Al Aseri and colleagues at King Saud University Medical City and […]