Coronary/Structural Heart

US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction

– Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction – FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. with heart failure with preserved ejection fraction, […]

FDA Approves Treatment for Wider Range of Patients with Heart Failure

SILVER SPRING, Md., Feb. 24, 2022 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control […]

JAMA Publication Highlights VASCEPA® (Icosapent Ethyl) Cardiovascular Risk Reduction Extends to Cost Effectiveness at Patient Level

Extensive analysis for U.S. by MedStar Health Research Institute determined icosapent ethyl is cost-effective compared to standard of care, both during the REDUCE-IT® clinical trial period and over a lifetime projection BRIDGEWATER, N.J., Feb. 24, 2022 (GLOBE NEWSWIRE) — JAMA Network Open has published “Cost-effectiveness of Icosapent Ethyl for High-risk Patients With […]

Arrowhead Completes Enrollment in Phase 2b ARCHES-2 Study of Investigational ARO-ANG3 for Patients with Mixed Dyslipidemia

– Topline data expected in the first half of 2023 PASADENA, Calif.–(BUSINESS WIRE)–Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has reached full planned enrollment of more than 180 participants in the Phase 2b ARCHES-2 clinical study of ARO-ANG3, the company’s investigational RNA interference (RNAi) therapeutic being developed as […]

Teleflex Receives FDA Clearance for Expanded Indication for Specialty Catheter and Coronary Guidewire Use in CTO PCI Procedures

Results of CTO-PCI IDE Study Demonstrate Procedural Success with Teleflex Specialty Catheters and Coronary Guidewires in Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Interventions WAYNE, Pa., Feb. 23, 2022 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the U.S. Food and […]

SyMap Medical Ltd Completed Enrollment in SMART Study for the Treatment of Uncontrolled Hypertension

SUZHOU, China, Feb. 23, 2022 /PRNewswire/ — SyMap Medical Ltd. (Suzhou, China) announced successful completion of enrollment in the company’s SMART Study (Sympathetic Mapping/Ablation Renal nerves for Treatment of hypertension Trial; NCT02761811), using the SyMapCath I™ Catheter/SYMPIONEER S1™ Mapping/RF System for the treatment of uncontrolled hypertension. This is the first pivotal study for registration purpose, worldwide, using […]

Cytokinetics Announces Start of SEQUOIA-HCM, a Phase 3 Clinical Trial of Aficamten in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Pivotal Trial to Assess the Potential of Aficamten to Improve Exercise Capacity, Heart Failure Symptoms and Functional Class SOUTH SAN FRANCISCO, Calif., Feb. 23, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), a Phase 3 clinical trial of aficamten in patients with symptomatic obstructive […]

Saranas® Expands Intellectual Property with Key Patent Integrating Bleed Monitoring and Vascular Access Closure Device

HOUSTON–(BUSINESS WIRE)–Saranas, a company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications, announced today that the U.S. Department of Commerce’s United States Patent and Trademark Office (USPTO) has issued them Patent No. 11,224,414. Titled “Access Closure with Bleed Monitoring,” this key patent allows for embedding […]

Claritas Announces Receipt of Comments from Australian Ethics Committee Regarding the Company’s Phase 1 Clinical Study of R-107 and Closing of Financing

SAN FRANCISCO, CA and TORONTO, ON , Feb. 22, 2022 (GLOBE NEWSWIRE) — Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the “Company” or “Claritas“) today announced that it has received comments from the Australian Human Research Ethics Committee (the “HREC”) regarding the Company’s Phase 1 clinical study of R-107, and […]

Abbott’s CardioMEMS™ HF System Receives FDA Approval to Support Patients Battling Earlier-Stage Heart Failure

– New expanded indication provides patients suffering from earlier stages of heart failure access to the CardioMEMS™ HF System, a small implantable sensor that can flag early warning signs of worsening heart failure – FDA approval was supported by data from the GUIDE-HF trial, which suggested that the CardioMEMS sensor […]