What could be Cytokinetics Inc.’s first approved drug will take center stage Dec. 13 at a meeting of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee. But judging from the FDA’s briefing document for the meeting, the spotlight on the heart failure drug, omecamtiv mecarbil, could be harsh.
The ability to inexpensively predict events such as stroke and heart attack is something of a holy grail for cardiologists, and a new study presented at this year’s annual meeting of the Radiological Society of North American (RSNA) provides just that capability. A study of an algorithm developed to examine a single chest X-ray suggests that the data generated by the algorithm can be as effective in establishing the patient’s risk of these events as a standard approach that relies on information that isn’t always readily available to the clinician.
Endologix LLC reported 12-month results from the second of two studies of a fully percutaneous, transmural arterial bypass therapy for treating peripheral arterial disease. Presented at this month's annual Vascular Interventional Advances Conference in Las Vegas, the Detour-2 study revealed technical success in 100% of treated patients using the system which also surpassed a 30-day, major adverse event rate of just 7%.”
Jiangsu Bioda Life Science Co. Ltd.’s artificial blood vessel has gained class III medical devices approval from China’s NMPA, marking the first domestic artificial blood vessel to get such approval. Nantong, China-based Bioda’s vessel is used for aortic coarctation and aneurysms.
Sino Medical Sciences Technology Inc. received marketing approval from China’s NMPA for its drug eluting stent system to improve vascular stenosis in patients with localized ischemic heart disease. The product is designed to improve the speed of wound healing and accelerate the recovery of vascular endothelium after stent implantation. It fits vessels with a diameter of 2.25 mm to 4.00 mm and a lesion length of less than or equal to 40 mm.
Cordis Corp. entered an agreement to acquire M.A. Med Alliance SA (Medalliance) in a transaction valued at up to $1.135 billion. Cordis will invest $35 million initially and provide an upfront payment of $200 million at closing in 2023. Meeting regulatory milestones will kick in $125 million and commercial milestones through 2029 are tied to an additional $775 million.
Shanghai Microport Ep Medtech Co. Ltd. went public on the Shanghai Stock Exchange STAR Market and raised ¥1.17 billion (US$169.5 million) with its initial public offering. The company’s issue price was ¥16.51 per share. After opening at ¥15.50 per share, the share price dived to ¥13.15 at the closing of its first trading day. Microport Ep is an associated company of the Hong Kong-listed Microport Scientific Corp.
With the launch of the Mawi Heart Patch in the U.S., physicians and patients have a lightweight, wireless heart monitoring system that provides seven days of cardiac information. Using a disposable two-lead system affixed to the chest, the device provides a detailed report within 24 hours and can reduce time to diagnosis by 97%, Mawi Inc. said.
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.
Intravascular ultrasound (IVUS) is an established method for gaining an appreciation of the sources of closure of the coronary arteries, but its use in the peripheral vasculature is not quite as well established. Nonetheless a new paper makes the case that IVUS may be appropriate for widespread use in connection with diseases of the peripheral vasculature, a position that could lead to a considerable expansion of sales of IVUS systems.
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