News

CMS Grants Transitional Pass-Through (TPT) Payment for Shockwave’s Coronary IVL
June 12, 2021
Provides Incremental Reimbursement in Hospital Outpatient Setting SANTA CLARA, Calif., June 12, 2021 — Shockwave Medical, Inc., a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced that the Centers for Medicare & Medicaid Services (CMS) granted approval for a Transitional Pass-Thro
Neurescue’s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest
June 10, 2021
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Abbott Announces CE Mark for its Amplatzer Steerable Delivery Sheath, Enabling New Capabilities in Treating AFib
June 7, 2021
June 7, 2021 — "Abbott's Amplatzer Amulet has long been the LAA occlusion device of choice in Europe and Canada to reduce the risk of stroke and eliminate the need for blood thinning medication in patients with atrial fibrillation," said Réda Ibrahim, M.D., Montréal Heart Institute, who completed one of the first global procedures with the new system.
NCVH: Two-Year Data From the TOBA II BTK Clinical Trial Demonstrate Durability of Dissection Repair Below the Knee With the Philips Tack Endovascular System
June 3, 2021
Results show that first-of
Aortix System: Cardiologists at Henry Ford Hospital Are First in U.S. to Implant New Device to Treat Heart Failure, Improve Kidney Function
June 3, 2021
Thinner than a #2 pencil, the heart pump is being studied for boosting blood flow 
SVS: Propofol Use during Catheter-Directed Interventions for Intermediate-Risk Pulmonary Embolism is Associated with Major Adverse Events
June 2, 2021
Rosemont, Ill., June 2, 2021 – A single-center retrospective study suggests avoiding Propofol or intra-procedural sedation during catheter-directed interventions (CDIs) for intermediate-risk pulmonary embolism (PE) because it can have detrimental effects.
Edwards Receives Clearance For Hypotension Prediction Index Software For Noninvasive Acumen IQ Cuff
June 1, 2021
IRVINE, Calif., June 1, 2021 — Edwards Lifesciences announced that Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff has received U.S. Food and Drug Administration clearance.
ESC: Hypertension During Pregnancy Associated With Increased Risk of Stroke in Offspring
June 1, 2021
Sophia Antipolis, June 1, 2021:  A study in 5.8 million children has found a higher incidence of stroke four decades later in those whose mother had high blood pressure or pre-eclampsia while pregnant. The research is presented at ESC Heart & Stroke 2021, an online scientific conference of the European Society of Cardiology (ESC).1
JenaValve Technology Receives CE Mark for its Trilogy TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis
May 26, 2021
IRVINE, Calif., May 25, 2021 — JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve implantation (TAVI) systems (also referred to as TAVR, or transcatheter aortic valve replacement) for the treatment of aortic valve disease, today announced that it has received CE Mark for its Trilogy™ Heart Valve System for the treatment of both aortic
SIRONA Randomized, Controlled Trial Comparing Sirolimus Versus Paclitaxel Balloons for the Treatment of Peripheral Arterial Disease Progresses Rapidly
May 26, 2021
May 26, 2021 — Concept Medical Inc., focused on vascular intervention drug delivery devices, released a status update from the SIRONA Randomized Control Trial (RCT). This trial compares, head-to-head, SIROlimus versus Paclitaxel Drug-Eluting BallooN Angioplasty in femoropopliteal arterial disease.