The 2022 Transcatheter Cardiovascular Therapeutics annual meeting highlighted mostly positive outcomes from major trials conducted by nearly all the big players in the cardiac device market. Here’s our round-up of the meeting’s high points, with updates from Abbott Laboratories, Abiomed Inc., Boston Scientific Corp., Edwards Lifesciences Corp., Inari Medical Inc., Medtronic plc and Recor Medical Inc.
Transcatheter aortic valve replacement (TAVR) continues to grow, so it is little surprise that the 2022 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting featured multiple presentations about TAVR-related devices and outcomes. The American College of Cardiology/American Heart Association’s latest guidelines recommends TAVR for patients over age 80 and surgery for those under age 65. Those in the middle can go either way, depending on comorbidities and patient preferences.
In an unexpected turn of events, Medtronic plc presented results from the Symplicity HTN-3 trial at year 3 showed sustained reductions in blood pressure with radiofrequency renal denervation (RDN) for resistant hypertension, contrary to the trial’s results at the six-month mark—and it wasn’t alone in showing positive results for the procedure.
Medtronic plc’s insulin pump adds more than six hours to the time-in-range for people with type 1 diabetes compared to the current standard of care, a recently published study found. The closed loop system also provides a far simpler method for controlling blood glucose levels compared to the multiple daily insulin injections and intermittent scans from a continuous glucose monitor widely employed today. The Adapt study results appeared in Lancet Diabetes & Endocrinology on Sept. 1.
The use of leads for cardiac electrophysiology devices has proven nothing short of controversial in the past, usually an artifact of efforts to craft ever-skinnier leads that won’t disrupt the blood vessels into which they are placed. Dublin-based Medtronic plc is working to avoid these problems with leads without sacrificing the advantages of leads via its EV ICD system, which soundly passed the test in a study presented at this year’s edition of the European Society of Cardiology (ESC) annual scientific sessions.
Integra Lifesciences Holdings Corp., of Plainsboro, N.J., said in its latest 8K filing that it has decided to voluntarily remove all the company’s Cerelink systems – which are indicated for intracranial pressure monitoring – due to customer reports that these monitors were returning inaccurate pressure readings.
Litigation over how to assign royalties for intellectual property with an offshore subsidiary doesn’t consume the kind of billable attorney hours that patent disputes do, but the question can affect a multinational corporation’s bottom line in significant ways. The U.S. Tax Court recently decided on a method for assigning royalties to a Medtronic plc subsidiary located in Puerto Rico that fell between the rate sought by Medtronic and the rate sought by an appeals court, but that ultimate rate was close to that preferred by Medtronic, handing the company a better outcome than it might have predicted when the IRS filed suit.
The U.S. FDA has identified a recall of Medtronic cardiac electrophysiology devices as a class I event due to the risk of an inadequate delivery of energy to restore normal rhythm, a recall that affects more than 87,700 units in total. Dublin-based Medtronic plc., said, however, that it is developing a software patch that will remedy the issue, a fix the company said will emerge in late 2022.
Medtronic plc inked an agreement to combine its patient care technologies with a wearable, remote monitoring platform developed by Pasadena, Calif.-based Rockley Photonics Inc. The Bioptx contains compact, photonics-based sensors inside a wristband to monitor a range of biomarkers beyond standard blood pressure, heart rate, pulse oximetry and glucose levels, making Rockley and Medtronic’s development partnership, said Rockley Chair and CEO Andrew Rickman, “a terrific match.”
The U.S. Centers for Medicare & Medicaid Services (CMS) has wrapped up its rulemaking for the next Medicare inpatient prospective payment system, and several companies managed to score important rate-setting wins for their devices. Microtransponder Inc., of Dallas, won a new technology add-on payment (NTAP) for its Vivistim device for treatment of stroke, as did W.L. Gore & Associates Inc. for its TAG thoracic branch endoprosthesis (TBE), just two among several winner in the Medicare inpatient final rule for fiscal 2023.
