Shockwave Medical Inc. will acquire Neovasc Inc. for just under $108 million, if all terms of the deal are met. Shockwave will pay $27.25 in cash for each of Neovasc’s 2.71 million outstanding shares or approximately $73.78 million at close. Shockwave said the offer corresponds to an enterprise value of $100 million. Neovasc could receive an additional payment of up to $47 million, if the company’s Reducer system for refractory angina obtains U.S. FDA marketing approval within a specified time frame.
Sonoscape Medical Corp. obtained marketing approval in China for its intravascular ultrasound (IVUS) diagnostic device and intravascular ultrasound diagnostic catheter.
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.
Rainmed Medical Ltd.'s coronary angiography-derived fractional flow reserve system (caFFR system) was approved by Australia’s TGA for precision diagnosis of coronary artery diseases.
Lepu Medical Technology (Beijing) Co. Ltd. received marketing approval from China’s NMPA for its peripheral cutting balloon to treat peripheral arterial disease.
Researchers from University Hospital Bonn presented data from a study that aimed to evaluate the significance of serum levels of the endoplasmic-reticulum-stress chaperone GRP78 in patients undergoing coronary angiography for suspected coronary artery disease (CAD).
The notion of a device that disappears from the human body once its work is done has driven massive investments in bioresorbable coronary artery scaffolds and stents, but these devices have had a difficult time getting to and staying on the market. The U.K. National Institute of Health and Care Excellence determined recently that these devices are not ready for routine use and should be deployed only in clinical trials.
Medtronic plc has entered a strategic collaboration with Cathworks Ltd. to expand the reach of Cathworks’ artificial intelligence (AI) guidance system for coronary artery disease management. Medtronic will invest up to $75 million and immediately begin co-promotion of the Ffrangio system on the U.S., European and Japanese market. As part of a separate agreement, Dublin-headquartered Medtronic will have the option to acquire Cathworks once certain undisclosed milestones are met.
The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
The eyes may be the window to the heart as well as the soul – particularly, to whether that heart is at risk of an infarct, researchers reported last week at the annual congress of the European Society of Human Genetics.
