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.
The PMA for the Neovasc Reducer device for treatment of drug-refractory angina faltered at an Oct. 27 U.S. FDA advisory committee, but it wasn’t for lack of support from star-power cardiologists. Gregg Stone, of the Cardiovascular Research Foundation, gave an impassioned plea for approval, pointing out that these patients have few options if they are poor candidates for bypass grafting or percutaneous coronary intervention. Stone said, “this is really a desperate patient cohort,” adding that a two-class improvement in angina severity “is a robust reduction.”
Abbott Laboratories saw improvement with its medical devices and diagnostics in the third quarter, which featured wins in the areas of COVID-19, diabetes, and structural heart. The company revealed its quarterly results on a Oct. 21 call, during which management said it was increasing its guidance for full-year adjusted earnings per share (EPS) to at least $3.55.
PERTH, Australia – During the COVID-19 pandemic, 90% of Australia’s clinical trials were put on hold, and the market cap of biotech and medical device companies on the Australian Securities Exchange dropped 5% to AU$11 billion (US$7.78 billion), according to a recent report by Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre.
PERTH, Australia – During the COVID-19 pandemic, 90% of Australia’s clinical trials were put on hold, and the market cap of biotech and medical device companies on the Australian Securities Exchange dropped 5% to AU$11 billion (US$7.78 billion), according to a recent report by Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre.
As with many conferences, the Cleveland Clinic’s 2020 Medical Innovation Summit went virtual this year. Still, the event featured the hotly anticipated top 10 list of innovations for 2021 that saw a range of therapies. Ranked in order of expected importance, the list was led by gene therapy for hemoglobinopathies. The top three innovations, including a novel drug for primary-progressive multiple sclerosis and smartphone-connected pacemaker devices, were highlighted in a special presentation.
As of Aug. 13, more than 90,000 patients hospitalized in the U.S. with COVID-19 already had been given access to convalescent plasma through a national expanded use protocol (EAP) sponsored by the Mayo Clinic. The FDA’s decision Sunday to grant emergency use authorization (EUA) for the potential therapy will further expand access to convalescent plasma for hospitalized patients throughout the country at a time when fully approved COVID-19 treatments are nonexistent and even EUAs are few and far between.
The COVID-19 pandemic has exerted a massive effect on procedure volumes across the globe, but concerns over supply chains have prompted political officials in Washington to encourage domestic production of drugs. That approach is also in play in a number of nations in the Asia-Pacific region, said Sana Siddiqui of Decision Resources Group, who noted that Beijing wants hospitals in China to ensure that 70% of devices used there are domestically manufactured by 2025.
While the U.S. and other countries are looking to step up their own domestic drug and device manufacturing, a bigger takeaway from the COVID-19 pandemic is the need for resilient supply chains that can withstand a global scramble for products suddenly more in demand than the supply can support.
While the U.S. and other countries are looking to step up their own domestic drug and device manufacturing, a bigger takeaway from the COVID-19 pandemic is the need for resilient supply chains that can withstand a global scramble for products suddenly more in demand than the supply can support.