FDA has issued another set of breakthrough device designations with cardiovascular disease devices again at the fore, and Cook Medical among those winning enhanced regulatory advice.
Cook received breakthrough status for its Zenith Fenestrated+ Endovascular Graft. The device, the first from Cook to receive breakthrough designation, is designed for use in certain patients with aortic aneurysms. Cook plans to file to run a pivotal clinical trial later this year.
Inovise Medical also recently received breakthrough status for its Audicor heart failure management system. The noninvasive system assesses the mechanical efficiency and electrical activity of the heart using algorithms that enable people previously hospitalized for heart failure to detect the risk of decompensation at home.
FDA also awarded breakthrough status to Cerus Endovascular for its Contour Neurovascular System. The device consists of fine mesh braid intended to treat intracranial aneurysms. Cerus said the device is unique as it "targets the neck of the aneurysm, away from the vulnerable dome."
BrainQ is the other recent recipient of FDA breakthrough status for a cardiovascular disease device. FDA granted the designation for an electromagnetic field therapy designed to improve the recovery from stroke. The device applies a machine learning algorithm to brainwaves and delivers a frequency-tuned low intensity electromagnetic field based on the analysis.
Away from the cardiovascular disease space, FDA recently awarded breakthrough designations to a number of other companies.
Anuncia secured the status for a device designed for use in the treatment of cerebral spinal fluid disorders requiring shunting such as hydrocephalus. The device, branded ReFlow System Mini, is designed to prevent blockages in intracranial shunts.
FDA granted breakthrough status to BrainCool for a system to prevent oral mucositis, a side effect of cancer therapy that can stop physicians from giving the most effective dose. BrainCool's single-use intraoral Cooral System is designed to stop the condition from developing by cooling the back of the mouth.
Dascena received breakthrough designation for an algorithm for detecting gastrointestinal bleeding. The Gibras cloud-based software uses machine learning to analyze the electronic health records of hospitalized adults. Through the analysis, Dascena aims to enable early detection of gastrointestinal bleeding.
FDA awarded breakthrough status to Locate Bio for the cartilage regenerative product Chondro3. The product is a biomimetic graft for tears or fractures that damage cartilage and underlying bone, known as osteochondral lesions. By providing a scaffold at the lesion site, Chondro3 is designed to support the repair of cartilage and bone.
Finally, Apollo Endosurgery picked up a breakthrough designation for its Orbera Intragastric Balloon in certain patients with noncirrhotic nonalcoholic steatohepatitis (NASH). The device consists of a balloon that is put into the stomach and filled with saline in an endoscopic procedure. Apollo has sold the device as a weight loss system in the U.S. since 2015. The breakthrough designation furthers Apollo's effort to expand into NASH.
