Surgical aortic valve replacement (SAVR) devices are widely believed to be considerably more durable than transcatheter aortic valve replacement (TAVR) devices, but five-year data for Medtronic plc’s Corevalve Evolut, presented this week at the Cardiovascular Research Technologies Conference in Washington, seem to suggest that TAVR devices are closing that gap.
Abbott Laboratories continues to push its presence in the cardiovascular market with offerings for the left atrial appendage (LAA) closure and transcatheter aortic valve implant (TAVI) markets, both of which generated affirmative data presented at this year’s edition of the annual meeting of Cardiovascular Research Technologies (CRT 2023) in Washington.
The U.S. FDA announced Feb. 27 that it is aware of data that suggest that the Trifecta surgical aortic valve replacement (SAVR) devices are potentially prone to early structural deterioration that could compromise both valve performance and valve durability.
The European Health Data Space (EHDS) proposal is designed to standardize practices for transmission and other sharing of health information, but this proposal is far from the only significant development coming out of Brussels.
Manufacturers of contact lenses may or may not want prescribers to be agnostic as to brand, but the U.S. Federal Trade Commission’s (FTC) contact lens rule requires that prescribers give the prescription to the customer when the eye exam is complete.
The U.S. Supreme Court has declined to grant cert for a petition filed by Johnson & Johnson on behalf of its Ethicon subsidiary to review a case in California that will cost the company more than $300 million. The outcome highlights the differential hazards of advertising and promotion in various U.S. states, with California state law allowing fines of up to $2,500 for each violation of state law, an amount that can quickly tally into the hundreds of millions.
The U.S. CMS has unveiled a proposed national coverage determination for powered seat elevation systems for Group 3 power wheelchairs, one of the more expensive items in the category of mobility durable medical equipment (DME). However, the agency indicated that it will soon examine coverage of powered seat elevation systems for Group 2 power wheelchairs, the combination of which suggests that manufacturers in the DME space are looking at a market that seems poised to explode.
GE Healthcare Technologies Inc. reported a recall of several systems in its nuclear medicine line of high-end imaging systems for two potential issues that could lead to the collapse of a detector weighing more than half a ton onto the patient. According to the U.S. FDA listing for the recall, no injuries or fatalities have been reported in connection with these issues, but the announcement resurrects an episode from 2013 in which a patient in New York lost his life when a nuclear imaging camera collapsed during an imaging procedure.
Alivecor Inc. has nudged the U.S. International Trade Commission (ITC) into issuing a limited exclusion order for products by Apple Inc. that are said to violate patents held by Alivecor, but there is one more stage gate to go for Alivecor. The ITC order notes that the exclusion won’t go into force until resolution of an inter partes review (IPR) involving the two firms, a process that could devour as much as a year and a half before a resolution is available.
The U.S. FDA recently proposed a modest overhaul of the rules pertaining to radiological products and other categories of products in an effort to eliminate duplicative or obsolete rules, such as a requirement for triplicate reports for variances in system performance.
