Johnson & Johnson halted the limited rollout of its Varipulse pulsed field ablation system on Jan. 5 to “investigate the root causes of four reported neurovascular events in the U.S. external evaluation.” So far, just 130 cases have been completed in the U.S. since the company received U.S. FDA approval in November for use in paroxysmal atrial fibrillation.
In early validation of widespread predictions of a robust year for M&A activity, Boston Scientific Corp. signed a definitive agreement to acquire the 74% of Bolt Medical Inc. it doesn’t already own for $443 million up front and up to $221 million in contingent milestone payments.
Medtronic plc received CE mark approval for its Harmony transcatheter pulmonary valve system to treat congenital heart disease patients with native or surgically repaired right ventricular outflow tract pulmonary regurgitation.
A spate of year-end collaborations highlights growing enthusiasm for expanding use of automated insulin delivery devices or pumps in management of type 1 diabetes only to include many patients with type 2 diabetes. Beneficiaries include pump makers Tandem Diabetes Care Inc., Insulet Corp. and Medtronic plc as well as the leaders in the continuous glucose monitoring market, Abbott Laboratories and Dexcom Inc.
The force is with Field Medical Inc. as it celebrates the U.S. FDA’s decisions to grant breakthrough device designation (BDD) to its Fieldforce ablation system and to accept it into the agency’s Total Product Life Cycle Advisory Program pilot. Field Medical designed the Fieldforce pulsed field ablation catheter specifically to treat ventricular tachycardia. The BDD applies to its use in monomorphic scar-related VT.
Although there is a clear clinical need for transcatheter mitral valve replacement technologies, a number of challenges must be overcome before they can safely be used to treat patients with mitral regurgitation. Nevertheless, two new devices could enter the European market next year, Edwards Lifesciences Corp.’s Sapien M3 and Highlife Medical SAS’s Highlife TMVR device.
Medtronic plc and Tempus AI Inc. launched the ALERT study to better understand and address the racial, ethnic, gender and geographic disparities associated with guideline-recommended treatments for aortic stenosis and mitral valve regurgitation. Currently, white patients represent 91% of people who receive TAVR procedures, a minimally invasive procedure that sharply reduces complications and improves quality of life in patients with narrowed heart valves.
While women with “big hearts” play well in popular culture, cardiologists see a very different picture – with significant implications for women’s health and medical care. Women have smaller hearts and narrower blood vessels than men and their cardiovascular systems respond to disease and treatment in very different ways. Growing evidence that failure to reflect women’s distinct anatomy in cardiac care leads to deadly disparities in outcomes has recently stimulated development of new diagnostics and increased focus on inclusion of women in medical device trials.
Medtronic plc obtained a CE mark for its next generation Endoflip 300 system which measures pressure and dimensions in the esophagus and pylorus, in adults. The Endoflip can be used to help diagnose and treat thousands of people across Europe suffering with esophageal motility disorders.
Johnson & Johnson received U.S. FDA investigational device exemption to begin the pivotal clinical trial for the Ottava robotic surgical system. If the trial goes well, Ottava could pose a significant challenge to decades-long dominance of the robotic surgical market by Intuitive Surgical Inc.’s Da Vinci system.
