Boston Scientific Corp. said it is initiating a global, voluntary recall of all unused inventory of the Lotus Edge aortic valve system, blaming complexities associated with the product delivery system. The Marlborough, Mass.-based company emphasized that the valve itself continues to achieve positive and clinically effective performance post-implant. However, because of the time and investment needed to develop and reintroduce a delivery system, the company believes it is necessary to retire the entire Lotus platform immediately.
KARACHI, Pakistan – Pakistan is taking steps to produce coronary stents domestically as a way to improve the delivery of health care at home and, perhaps, tap into a growing global market.
N-ovative Health Technologies Pvt. Ltd., spun out of the National University of Science and Technology (NUST), started mass production of cardiac stents and angioplasty balloon catheters in October. It is the first such manufacturing facility in the country.
Adagio Medical Inc., a company focused on the treatment of atrial fibrillation (AF) and ventricular tachycardia (VT), has scooped up $42.5 million in a series E equity financing. The funds are earmarked for the ongoing IDE trial of its intelligent Continuous Lesion Ablation System (iCLAS). They will also be used to accelerate the European VT CE mark study, advance the commercialization of iCLAS in CE-mark countries and further development and clinical validation of its pulsed field cryoablation technology.
Keeping you up to date on recent developments in cardiology, including: New cardiac arrest resuscitation treatment demonstrated 100% success rate in cannulation; How additional heart imaging can help certain women; Heart development protein has role in adult immunity.
Acutus Medical Inc. posted strong results for the third quarter of 2020, despite the ongoing uncertainties of the COVID-19 pandemic. Sales for the quarter totaled $3.2 million, up 180% sequentially and 391% when compared with the same period in 2019.
Keeping you up to date on recent developments in cardiology, including: What is causing COVID-19 blood clots?; Using machine learning to predict survival rates with OHCA; Remote cardiac rehabilitation proves itself.
Boston Scientific Corp. has scooped up an approval from the U.S. FDA for the Ranger drug-coated balloon to help those with peripheral artery disease in the superficial femoral artery and proximal popliteal artery.
Keeping you up to date on recent developments in cardiology, including: Mobile smartphone tech tied to better clinical outcomes for OHCA; Lung scans for earlier COVID-19 detection; Cholesterol meds affects the organs differently.
PARIS – Fineheart SA has announced the success of a 30-day preclinical trial to evaluate its implantable cardiac output management system (ICOMS) for patients suffering from severe heart failure. The device was well-tolerated with no related adverse events seen during the 30 days.
Premarket approval by the U.S. FDA of a new venous stent system made by Medtronic plc could blast through impediments for patients who suffer from complex deep vein obstruction. Less than 1% of patients with iliofemoral venous outflow obstruction currently receive treatment, despite the risk of serious complications and sharply reduced quality of life. Approval of the Abre stent was based on a 200-patient clinical study.
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