Coronary/Structural Heart

Hatch Medical and VascuTech Medical Partner to Commercialize Advanced Radial Sheath and Micro-Introducer Lines

SANTA ROSA BEACH, Fla., Oct. 20, 2020 (GLOBE NEWSWIRE) — Medical device incubator and technology brokerage firm, Hatch Medical, L.L.C. (www.hatchmedical.com) announced recently that it has entered into an exclusive brokerage relationship with VascuTech Medical and Interventional Radiologist Jonathan Levine, MD for their next generation sheath technology. “Dr. Levine, a […]

CARMAT Obtains ANSM Approval to Resume PIVOTAL Study Implants in France

PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces that it has obtained ANSM (French agency for the safety of […]

PleuraFlow Shown to Enable Improved Outcomes for Cardiac Surgery Patients in New Clinical Study Results

Reduction of Patient Complications After Heart Surgery Demonstrated with Use of the ClearFlow’s PleuraFlow ACT System IRVINE, Calif.–(BUSINESS WIRE)–ClearFlow, Inc., a medical device company based in Irvine, California, has announced positive clinical trial results presented at the 2020 Virtual Program of the Annual Eastern Cardiothoracic Surgical Society Conference (ECTSS) on […]

Organicell Partners with Regenerative Care Network to Study Potential Therapeutic Benefits of Zofin™ for Patients with Heart Failure

MIAMI, Oct. 20, 2020 (GLOBE NEWSWIRE) — Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced that it has recently entered into an agreement with Regenerative Care Network (“RCN”). Organicell and RCN plan to collaborate on clinical research projects investigating use […]

OPTIMIZE Study Reports Lowest TLR Ever Achieved in an Investigational Device Exemption (IDE) Study With Svelte Medical System’s Bioresorbable Coated Drug-Eluting Coronary Stent

OPTIMIZE Pivotal Study 1 Year Outcomes Announced at TCT Connect NEW PROVIDENCE, N.J.–(BUSINESS WIRE)–The Svelte® Drug-Eluting Stent (DES) achieved 1.5% clinically-driven Target Lesion Revascularization (TLR) at 1 year, the lowest ever reported in an Investigational Device Exemption (IDE) clinical study. Primary and secondary endpoint outcomes of the OPTIMIZE IDE study, designed […]

Cardiac Dimensions Announces up to 7.5 Year Data on the Carillon® Mitral Contour System

Have you seen the exciting new publication by Dr. Janusz Lipiecki and team, Long-term prognosis of patients treated by coronary sinus-based percutaneous annuloplasty: single centre experience, published in ESC Heart Failure 2020? This publication is Cardiac Dimension’s sixth this year! The company continues to release data which confirms the Carillon Mitral Contour System’s importance in the treatment of heart […]

CeloNova Announces Late-Breaking Evidence From First-Ever Randomized Controlled Trial Evaluating 14-Days DAPT In Complex Patients At High Bleeding Risk Following PCI

The novel non-DES, non-BMS COBRA PzF NanoCoated Coronary Stent (NCS) with just 14-days DAPT demonstrated statistically less bleeding (BARC 1-5) compared to the DES arm at 3 or 6 months DAPT post-PCI, low 0.6% ST and low 3.7% ischemic-driven TLR at 6 months. SAN ANTONIO, Oct. 17, 2020 /PRNewswire/ —  CeloNova BioSciences, Inc. (CeloNova), […]

Data Presented at TCT Connect Finds Pre-PCI Use of Impella for AMI Cardiogenic Shock is Associated with Higher Survival, Particularly in Women

DANVERS, Mass.–(BUSINESS WIRE)–Two studies of AMI cardiogenic shock (AMICS) patients found higher survival when Impella was placed pre-PCI, compared to when Impella was placed after PCI. The findings were presented at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation. In the first study, presented by Hemindermeet Singh, […]

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). […]