Coronary/Structural Heart

Vivasure Medical Announces Enrollment of First Patients in Pivotal PATCH Study

Study will evaluate the safety and efficacy of Vivasure’s PerQseal Closure Device System designed for large arteriotomies GALWAY, Ireland–(BUSINESS WIRE)–Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the first patients in the company’s PerQseal® PATCH Clinical Study, a multi-center, single-arm, pivotal […]

Sequana Medical announces FDA clearance of IND application for DSR® 2.0 for treatment of congestive heart failure

MOJAVE study on track to start in Q2 2023 as planned, with initial data by year-end Randomized, controlled study in US seeking to confirm strong efficacy data seen in RED DESERT and SAHARA studies DSR well positioned as disease-modifying heart failure therapy Ghent, Belgium – 02 May 2023 – Sequana Medical NV (Euronext […]

Tenaya Therapeutics Receives FDA Fast Track Designation for TN-201

TN-201 Being Developed for the Potential Treatment of MYBPC3-associated HCM Dosing in Phase 1 Clinical Trial Expected to Commence in Q3 2023 SOUTH SAN FRANCISCO, Calif., May 02, 2023 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially […]

Mineralys Therapeutics Announces First Patient Dosed in the ADVANCE-HTN Pivotal Trial of Lorundrostat for the Treatment of Uncontrolled and Resistant Hypertension

– Topline data from the trial are expected in the first half of 2024 – – A second, pivotal trial of lorundrostat in uncontrolled and resistant hypertension expected to commence enrollment in the second half of 2023 – RADNOR, Pa., May 02, 2023 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), […]

Elixir Medical To Announce Late-Breaking Clinical Data at EuroPCR 2023 Session Featuring World’s First Transforming Coronary Artery Implant Designed to Restore Vessel Physiology and Function

– 12-month clinical and imaging data from first multicenter, international, randomized controlled trial of DynamX® Bioadaptor vs. Resolute OnyxTM to be presented Wednesday, May 17 – – Elixir Medical’s DynamX Bioadaptor goes beyond traditional caged tube drug-eluting stents (DES), or the promise of bioresorbable scaffolds (BRS), and is designed to restore flow, […]

New Family Heart Foundation Study Reveals Systemic Underdiagnosis and Undertreatment of Homozygous Familial Hypercholesterolemia

Published in JAHA, Study Shows Delayed Diagnosis of HoFH, a Rare Disease, Leads to Premature Cardiovascular Disease PASADENA, Calif.–(BUSINESS WIRE)–A new study from the Family Heart Foundation, a leading research and advocacy organization, showed the diagnosis and treatment of homozygous familial hypercholesterolemia (HoFH) is delayed, and often occurs after a heart […]

Concept Medical received IDE approval to investigate safety and efficacy of its MagicTouch Sirolimus Coated Balloon Catheter for the treatment of small coronary artery disease

TAMPA, Fla., May 1, 2023 /PRNewswire/ — The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc’s novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries. US FDA, on the 25th of April 2023, granted the third IDE approval for Concept Medical’s Sirolimus Coated Balloon […]

Casana Receives FDA Clearance for Heart Health Smart Toilet Seat

Casana obtained FDA clearance for measuring Heart Rate (HR) and Oxygen Saturation (SpO2) Sensors embedded in the toilet seat enable effortless measurement of these vital signs Casana will pursue subsequent filings, including Systolic and Diastolic Blood Pressure (BP), with the target of an initial product market launch by the end […]

Silence Therapeutics Completes Enrollment in Phase 2 Study of Zerlasiran (SLN360) in Subjects with Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events

LONDON–(BUSINESS WIRE)–Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the Company”), an experienced and innovative biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines, today announced that it has completed enrollment in the ALPACAR-360 phase 2 study of zerlasiran (SLN360) in subjects with elevated lipoprotein(a) (“Lp(a)”) […]

Therapeutic Solutions International Launches VasoSome Vascular Inc Based on Successful Treatment of Aortic Aneurysms using Patent Pending Exosome Therapy

Clinical Stage Company Expands Regenerative Medicine Franchise into 4 billion Dollar Aneurysm Market ELK CITY, Idaho–(BUSINESS WIRE)–Therapeutic Solutions International (TSOI) announced formation of a new spin-off company, VasoSome Vascular Inc, focused on treating the “living timebomb” condition of aortic aneurysms using stem cell derived exosomes. The aorta is the body’s […]