During the week of July 24, 2023, the FDA published several notifications of potentially elevated risks associated with medical devices, including a recall of a delivery sheath for the Amplatzer device by Abbott Laboratories. The agency also announced that Abiomed Inc. will provide a correction for the instructions for use (IFUs) for the Impella because of an issue seen when implanting the left ventricular assist device in patients with transcatheter aortic valve replacement (TAVR) devices.
Arsenal Medical Inc. said its Neocast embolic material for neurovascular conditions was successfully used to treat its first patient. The patient was embolized as part of a first-in-human study to assess the safety and feasibility of Neocast for the embolization of brain tumors to more easily enable surgical removal.
The U.K. government and the health care industry should focus more on behavioral-based approaches and preventative care in a bid to tackle health inequality, rising costs and an ageing population, Anton Derlyatka, CEO and co-founder of Sweatcoin Ltd., told BioWorld. Sweatcoin is a step-counting app that rewards users for their daily steps. The company has worked with the NHS for the last three years and is currently working on pilot programs to help tackle type 2 diabetes and cardiovascular diseases by incentivizing people to move.
Australia’s Therapeutic Goods Administration (TGA) is reconsidering its approach to regulating devices that bear materials of animal, microbial or recombinant origin, a broad class of products that includes transcatheter aortic valve replacement (TAVR) devices.
Taking a step forward in an increasingly crowded market that has long been dominated by non-Chinese players, Magassist Co. Ltd. got positive clinical results from its extracorporeal membrane oxygenation (ECMO) system Breathmo to provide support for patients with serious heart failure or lung failure, with a study showing that the system can provide pulmonary and cardiac support effectively and safely.
Recalls are a fact of life in the medical technology space, and Medtronic plc and Quidel Cardiovascular Inc., have both been forced to report class I recalls. Dublin-based Medtronic announced a recall of more than 348,000 cardiac electrophysiology devices due to issues that could prevent high-voltage therapy while San Diego-based Quidel is recalling nearly 7,800 Triage cardiac panels because of a risk of false negatives for patients being assessed for an infarct.
Shineco Inc.’s subsidiary Changzhou Biowin Pharma received marketing approval from China’s NMPA for its test device that can complete a diagnosis of acute myocardial infarction in five minutes. The five-minute cardiac test relies on a combination of three major cardiac markers that can detect cardiac troponin I, myoglobin and heart fatty acid binding protein in a single test.
Caristo Diagnostics Ltd. is deploying its medical imaging technology, Cari-Heart, at several NHS hospitals in a pilot project that will help identify patients at risk of heart attack years before it occurs. Cari-Heart detects signs of inflammation around coronary arteries. “No other company is doing this,” Frank Cheng, CEO of Caristo told BioWorld. “No one is using CT to quantify and visualize coronary inflammation” to predict the risk of a heart attack years in advance.
Lifetech Scientific Corp.’s fully degradable iron-based absorbable coronary scaffold showed its safety and efficacy to treat non-complex coronary lesions that have not been previously treated with an interventional device during a three-year, first-in-humans trial.
The U.S. CMS is proposing to expand coverage of angioplasty and stenting for the carotid arteries to include patients who currently cannot receive this treatment for carotid artery stenosis outside of a clinical trial, generally a cause for celebration among device makers. However, Silk Road Medical Inc. is one possible exception to the overall picture as utilization of its transcarotid artery revascularization (TCAR) system may suffer as a result.
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