FDA Grants Breakthrough Device Designations to Endologix and NeuroMetrix
The U.S. Food and Drug Administration (FDA) has recently granted Breakthrough Device Designation to two medical device companies, with California-based healthcare tech company Endologix leading the mix.
Endologix announced Monday the FDA granted the Breakthrough Device Designation to the company’s ChEVAS (Chimney Endovascular Aneurysm Sealing) system for patients with abdominal aortic aneurysm (AAA).
The company’s device is a combination of Endologix’s Nellix 3.5 endograft, featuring parallel visceral stents to treat juxtarenal, pararenal and suprarenal AAA. Currently, Endologix is investigating the device in the ChEVAS One investigational device exemption study. Lead enroller of the ongoing study, James McKinsey, M.D., said in a statement the system shows promise in this “challenging” patient population.
“The ChEVAS System represents an important therapy that provides an ‘off the shelf’ treatment to an underserved patient population who have complex abdominal aortic aneurysms,” according to a statement made by Matt Thompson, M.D., Endologix’s chief medical officer. “We are delighted that the FDA has designated ChEVAS as a Breakthrough Device, as this will facilitate our ability to develop this technology and make it available to patients in an expedited fashion.”
Dr. Thompson added the ChEVAS joins the PQ Bypass DETOUR System as another FDA-designated Breakthrough Device in the company’s “clinical investigational programs, which is reflective of our aspiration to provide innovative and disruptive technologies to address clinically relevant therapeutic gaps.”
Another company joining the group of organizations with recent device designations is NeuroMetrix, which announced on Tuesday the FDA granted Breakthrough Designation for the company’s Quell device for the treatment of fibromyalgia symptoms in adults. News of the designation resulted in NURO shares nearly tripling in value to $10.04 at the end of trading.
The non-invasive Quell nerve stimulation device is covered by a total of 18 utility patents in the U.S. It is a wearable neurostimulator that uses position and motion sensing to adjust stimulation automatically. The device is also used with the Quell app.
NeuroMetrix hopes this device, when ultimately approved, could meet the gaps in managing fibromyalgia symptoms found with current pharmacologic treatments. The FDA will provide the device priority review.
Breakthrough Designation was granted to the Quell device based on data from a double-blind, randomized controlled trial (NCT03714425). The study included 119 patients with fibromyalgia who were randomly assigned to either the Quell device or a modified sham control device for three months.
In the study, approximately 56% of patients who received the active Quell device had a clinically meaningful, greater improvement in health-related quality of life, which was significantly greater than the group which received the sham control (p=0.029).
“The Breakthrough Device Designation is an important milestone in the Company’s effort to make Quell technology available to people living with fibromyalgia,” said NeuroMetrix’s president and chief executive officer, Shai N. Gozani, M.D., Ph.D., in a statement. “We are moving forward with a regulatory filing that could position us to launch Quell for this indication in the second half of next year.”