Few disease states in the world of cardiology have been studied as persistently as atrial fibrillation (AF), but new study data presented in Chicago at the 2022 scientific sessions of the American Heart Association seem to advance the cause of an ablation-first strategy for some patients experiencing paroxysmal AF. The PROGRESSIVE-AF study demonstrated that patients who are ablated early in the disease cycle are less likely than those placed on drug management to experience recurrence and to be readmitted, just two of several findings that are driving cardiologists toward device therapy and away from drug therapy for their patients with AF.
Teleflex Inc. issued a recall of its Iso-Gard S filters for respiratory equipment due to reports of separation, a problem that could impede the delivery of oxygen to patients. The class I recall was driven by 36 complaints and four injuries reported to the U.S. FDA, and affects more than 60,000 units shipped between Sept. 1, 2020, and July 5, 2022.
The debate over medical management versus percutaneous coronary intervention (PCI) for patients with chronic coronary artery disease took a new twist thanks to data that PCI plus medical management was better than medical management alone for cardiovascular mortality.
The U.S. FDA held a two-day advisory hearing in the last week of October 2022 to address some lingering regulatory questions, including the question of whether therapeutic nail prostheses should be a class I device. The potentially more dramatic shift, however, would be the application of a class III risk designation to tissue expanders used in breast surgery.
The U.S. CMS had the usual mix of good news and bad news in its hospital outpatient final rule for calendar year 2023, which served up a plate of bad news for Brainscope Inc. and Elucent Medical Inc., which will enjoy no new technology pass-through (NTPT) payments in the coming year for their applications. Conversely, Carlsmed Inc. and Microtransponder Inc. both came out of the annual NTPT scrum with wins, thus ensuring they’ll be able to more rapidly recapture their med tech investments.
The U.S. Department of Justice (DOJ) reported that it has arrived at a settlement of $45 million with Boca Raton, Fla.-based Modernizing Medicine Inc., an electronic health record (EHR) vendor that was accused of inducing referrals to a clinical lab for pathology services. The department stated that this settlement was the fourth such action against EHR vendors and is part of a concerted DOJ effort to “root out fraud” in the field, a signal that more enforcement against these companies is in the works.
The U.S. CMS has finalized the physician fee rule for calendar year 2023, a document that imposes an across-the-board pay cut of approximately 4.5% for physician Medicare services. However, the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) blasted the final rule’s failure to provide what they believe are appropriate rates for cardiac ablation services, a position backed by two med-tech trade associations in their comments to the docket for the draft rule.
Shortages of medical devices were not particularly topical before the COVID-19 pandemic, but they have dotted the landscape in the past three years despite the U.S. FDA’s best efforts to manage such issues. The agency recently announced that tracheostomy tubes are now among the device types that are in a state of shortage, a problem created by a paucity of the raw materials used to manufacture these items.
The U.S. CMS has peeled back a proposed 4.2% rate cut in the home health payment draft rule for calendar year 2023, replacing it instead with a 0.7% increase in overall payments for home health services, a category that affects sales of durable medical equipment and home infusion therapy items. That change was insufficient to mollify the National Association for Home Care & Hospice (NAHC), which argued that the final rule will nonetheless severely hit home care providers and leaves NAHC with no choice but to take its concerns to Capitol Hill.
The U.S. FDA announced that it has cleared a new set of tubes used in hemodialysis machines made by Fresenius Medical Care AG & Co., of Bad Homburg, Germany, that are expected to overcome concerns about the previous tubes’ release of potentially toxic biphenyls. The agency acknowledged that it has no reports of adverse events related to the use of these chemicals in the silicone used to manufacture the tubes, stating that its action on this issue is driven solely by animal studies in the medical literature, none of which were cited in the FDA’s Oct. 28 announcement.
