Industry Press Releases

Oct 31, 2022 | Industry Press Releases
Impella RP Flex with SmartAssist Receives FDA Approval to Treat Right Heart Failure

Danvers, Mass., October 31, 2022 – Abiomed (Nasdaq: ABMD) announces that Impella RP Flex with SmartAssist has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA), the FDA’s highest level of approval, as safe and effective to treat acute right heart failure for up to 14 days.

Oct 18, 2022 | Industry Press Releases
MedAlliance to be Acquired by Cordis

GENEVA, Oct. 18, 2022 /PRNewswire/ — Swiss-based medical technology company MedAlliance has announced it has entered into an agreement with Cordis for an acquisition which includes an initial investment of $35M and upfront closing payment of $200M, regulatory achievement milestones of up to $125M and commercial milestones of up to $775M through 2029 for a total consideration of up to $1.135 Billion.

Oct 17, 2022 | Industry Press Releases
U.S. FDA Grants 510(k) Clearance for Impella Low Profile Sheath

The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed (Nasdaq: ABMD) for its Impella Low Profile Sheath. Compared to the existing 14 French (Fr) sheath used for placement of Impella CP, the new sheath maintains the same inner diameter, but reduces the outer diameter by nearly 2 Fr.

Sep 17, 2022 | Industry Press Releases
Unloading with Impella® for 30 Minutes Before PCI Associated with Reduced Infarct Size in STEMI Patients

BOSTON–(BUSINESS WIRE)–Results of a new per-protocol analysis of the ST-segment Elevation Myocardial Infarction Door-To-Unload (STEMI DTU) pilot trial data show significantly reduced infarct size in patients who received left ventricular (LV) unloading with Impella CP for 30 minutes prior to their percutaneous coronary intervention (PCI) compared to patients who received LV unloading followed by immediate PCI.

Sep 16, 2022 | Industry Press Releases
FDA Approves RECOVER IV Randomized Controlled Trial with Exception from Informed Consent (EFIC)

DANVERS, Mass. – September 16, 2022 – Abiomed (Nasdaq: ABMD) announces two approvals from the U.S. Food and Drug Administration (FDA) related to clinical research of Impella® heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients.

Sep 15, 2022 | Industry Press Releases
Edwards PASCAL Precision Transcatheter Valve Repair System Receives FDA Approval For Degenerative Mitral Regurgitation

IRVINE, Calif., Sept. 15, 2022 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), today announced the company’s PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) has received FDA approval for the treatment of patients with degenerative mitral regurgitation (DMR).

Sep 12, 2022 | Industry Press Releases
Edwards Launches SAPIAN 3 Ultra RESILIA Valve Following FDA Approval

IRVINE, Calif., Sept. 12, 2022 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced the launch of the SAPIEN 3 Ultra RESILIA valve, which incorporates Edwards’ breakthrough RESILIA tissue technology with the industry-leading SAPIEN 3 Ultra transcatheter aortic heart valve. The launch follows recent U.S. Food and Drug Administration (FDA) approval.

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