Guidant relaunches stent in Europe:
This article was originally published in Clinica
Executive Summary
Guidant has received CE-mark approval for the reintroduction of its Multi-Link Vision coronary stent system, which it voluntarily recalled in March 2003. The product was taken off the market after reports of the stent becoming dislodged from its delivery system (see Clinica No 1052, p 13), but Guidant says it has taken "corrective and preventive actions". The device, which was first introduced on a limited basis in February, uses a cobalt chromium alloy that is suitable for thin stent struts, and Guidant hopes to use it for its future drug-eluting stent programmes.
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.