The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will be venturing into new territory April 15 in which it not only has to consider whether the benefit of Celltrans Inc.’s donislecel is clinically meaningful, but it also will have to define the indication.
The shortage of hearts for transplant is a matter of record for both cardiologists and patients, a problem that Transmedics Inc. proposed to solve with its Organ Care System (OCS). Despite several significant issues associated with the pivotal clinical study for the OCS, Transmedics snared a 12-5 vote that the benefits of the system outweigh the risks, an outcome that may bring at least some relief for heart transplant patients by mid-year if analyst expectations are on target.
A U.S. FDA advisory committee voted 14 nays to three ayes that the benefits of the Lutonix 014 drug-coated balloon (DCB) do not outweigh the risks in a panel proceeding peppered by problems with missing data and a lack of operator blinding. The panel widely saw the use of paclitaxel-eluting technologies in other areas of the vasculature as a reassurance that this device might perform as promised, but the outcome nonetheless leaves the sponsor with a new round of negotiations with the FDA as to how to move forward.
Some PMA filings manage to scrape by at U.S. FDA advisory hearings, but the application for the Visability device by Refocus Group Inc. was not one of those. The panel voted 15-1 that the benefits of the device for presbyopia did not outweigh the risks, leaving the sponsor with a fundamental question about the viability of a technology that has been under development for more than 20 years.
The PMA for the Neovasc Reducer device for treatment of drug-refractory angina faltered at an Oct. 27 U.S. FDA advisory committee, but it wasn’t for lack of support from star-power cardiologists. Gregg Stone, of the Cardiovascular Research Foundation, gave an impassioned plea for approval, pointing out that these patients have few options if they are poor candidates for bypass grafting or percutaneous coronary intervention. Stone said, “this is really a desperate patient cohort,” adding that a two-class improvement in angina severity “is a robust reduction.”
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advisory hearing gives Neovasc Reducer poor marks for efficacy; CMS eyes expanded DME coverage of CGMs; APEC launches Vision 2025 for business ethics; Innovation Alliance voices support for Iancu, PTAB changes.
The second day of the U.S. FDA’s orthopedic devices advisory panel included a proposal to down-classify semi-constrained toe joint prostheses as class II devices, but the panel was adamant that such devices be slotted in class III, with one panelist referring to the literature for these devices as “garbage.”
The agenda for the U.S. FDA’s Sept. 8-9 advisory hearing includes a proposed down-classification of bone growth stimulator (BGS) devices to class II, but while the proposal met some resistance from an industry group, the panel sided with the FDA and declared BGS units ready for prime time as 510(k) devices.
Interludes of classical music. Little kids talking in the background. Unmuted mics as panelists multitask. Gurgles of “underwater” sound. Periods of silence as speakers forget to unmute. And then the technical problems – lots of them. Such are the challenges of addressing a virtual FDA advisory committee in the time of COVID-19.
The U.S. FDA's two-day advisory hearing on industrial ethylene oxide (EtO) sterilization of medical devices wrapped up with a discussion of how duodenoscopes can be made safer. The conclusion was largely that employee churn, training and work conditions were the biggest challenges – issues over which the FDA has nearly zero leverage.
