CE-mark for Baxter's mechanical heart valve:
This article was originally published in Clinica
Executive Summary
Baxter has CE-marked its bileaflet mechanical heart valve. The Edwards MIRA valve features a unique sewing ring and is suitable for a wide variety of surgical techniques, including minimally-invasive procedures. The company plans to begin clinical trials of the device in the US in 1998, pending approval of an investigational device exemption application by the FDA. Baxter estimated that over 250,000 patients worldwide undergo surgery every year to repair or replace diseased or defective heart valves.
You may also be interested in...
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.