The EU approved the first drug-coated balloon for treatment of in-stent restenosis nearly a decade ago, but U.S. physicians continue to have their hands tied in treating the fairly common problem. Results from Boston Scientific Corp.’s investigational device exemption trial for its Agent paclitaxel-coated balloon presented in San Francisco at Transcatheter Cardiovascular Therapeutics could finally put the tool in the hands of cardiologists. The device demonstrated a nearly 50% reduction in the risk of target lesion revascularization and target vessel myocardial infarction compared to conventional balloon angioplasty.
American pharma giant Bristol Myers Squibb Co. (BMS) will pick up the rights to Lianbio Co. Ltd.’s FDA-approved drug for obstructive hypertrophic cardiomyopath, Camzyos (mavacamten), in six Asian countries by paying $350 million up front and waiving some outstanding payments.
Ventric Health Inc. received U.S. FDA 510(k) clearance for its Vivio system, a mobile, non-invasive medical device that can aid in the diagnosis of heart failure. With early diagnosis crucial for treating and managing the condition, Vivio uses advanced algorithms to detect elevated left ventricular end diastolic pressure (LVEDP) in less than five minutes and can therefore improve clinical and health outcomes.
An analysis of real-world data pulled from Truveta’s electronic health records of 30 U.S. health care systems found that patients treated for pulmonary embolism (PE) using Boston Scientific Corp.’s Ekos endovascular system had lower rates of adverse events, particularly intracerebral hemorrhage, than those treated with Inari Medical Inc.’s Flowtriever system.
Anteris Technologies Ltd. presented multiple sessions at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 annual meeting in San Francisco this week on its novel Duravr biomimetic heart valve, a balloon-expandable, single-piece transcatheter aortic valve designed to closely replicate the shape and performance of a human aortic valve. The device was used for the first time earlier this year in a valve-in-valve replacement procedure and began its early feasibility study, both of which were reviewed at the cardiology meeting.
No matter how you look at it, guiding percutaneous coronary interventions to treat complex lesions with optical coherence tomography (OCT) or intravascular ultrasound (IVUS) produces similar results in patients with complex lesions, a study presented Oct. 23 at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco indicated.
Medtronic plc got a jump on its cardiology competitors with big news ahead of the Transcatheter Cardiovascular Therapeutics (TCT) conference that starts on Oct 24 in San Francisco, with U.S. FDA approval of its Aurora extravascular implantable cardioverter-defibrillator (EV-ICD). The system delivers defibrillation and heart pacing without placing wires in the heart or vasculature. That puts it in direct competition with Boston Scientific Corp.’s Emblem S-ICD, currently the only player in the market.
Danish obesity and diabetes drugmaker Novo Nordisk A/S is set to acquire the Singapore-based KBP Biosciences Co. Ltd.’s hypertension drug, ocedurenone (KBP-5074), for potentially $1.3 billion, creating a platform to increase its reach in the cardiovascular (CV) landscape beyond a crowding obesity market.
Haemonetics Corp. returned to the M&A trail with an agreement to buy Opsens Inc., a cardiology-focused medical device company, for CA$2.90 (US$2.13) per share for a total of CA$345 million (US$253 million). The all-cash transaction, its third significant purchase in five years, is expected to close by late January 2024, pending the approval of regulators and 66.66% of voting shareholders. Haemonetics expects the deal to be immediately accretive to adjusted earnings per share (EPS).
Small conductance SK (Ca) channel blockers, particularly SK (Ca) 2.3 (SK3; SKCa3; hKCa3) channel blockers, have been described in an Acesion Pharma ApS patent as potentially useful for the treatment of arrhythmia.
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