Infraredx Inc. announced the Makoto Intravascular Imaging System, and accompanying Dualpro intravascular ultrasound and near-infrared spectroscopy (IVUS+NIRS) catheter, is now available in Japan. The launch follows a successful Spring 2018 limited market release, which included more than 10 hospitals in Japan.

Medtronic plc announced the start of a pilot study of its investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, with the first patient implant performed at Christchurch Hospital in New Zealand. The implant represents the first intended long-term patient use of the device, which is similar in size to transvenous ICDs.

Boston Scientific Corp. announced it has signed an agreement to acquire Veniti Inc., which has developed and commercialized the Vici Venous Stent System for treating venous obstructive disease. Boston Scientific has been an investor in Veniti since 2016 and currently owns 25 percent of the company. The transaction price for the remaining stake consists of $108 million up-front cash, as well as up to $52 million in payments contingent upon U.S. Food and Drug Administration (FDA) approval of the Vici stent system.

Akcea Therapeutics Inc., an affiliate of Ionis Pharmaceuticals Inc., announced the publication of results from the first-ever study demonstrating the benefits of patient-to-patient connectivity in the management of familial chylomicronemia syndrome (FCS). FCS is a rare, potentially life-threatening disease with multiple severe, daily and chronic manifestations that affect one’s ability to work and engage in activities of everyday living. Results from the CONNECT study, which surveyed both FCS patients and their caregivers, were published in July in Expert Opinion on Orphan Drugs.

Boston Scientific Corp. announced it has recently closed its acquisition of Claret Medical Inc., a privately-held company that developed and commercialized the Sentinel Cerebral Embolic Protection System. The device is U.S. Food and Drug Administration (FDA)-cleared to protect patients against the risk of stroke in transcatheter aortic valve replacement (TAVR) procedures.

Thermedical announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for the Early Feasibility Study (EFS) of the company’s Durablate ablation catheter. The single-arm, observational study is designed to evaluate the safety and effectiveness of the Durablate catheter to treat ventricular tachycardia (VT), a leading cause of sudden cardiac death in the United States.