Abbott developed Triclip to enable surgeons to repair tricuspid valves that no longer close properly and therefore allow blood to leak back into the right atrium of the heart. Edwards Lifesciences won FDA approval for its transcatheter valve replacement device, Evoque, earlier this month.
J.P. Morgan analysts see “a place for both repair and replacement.”
On Tuesday, a panel of experts convened by the FDA will discuss whether the data on Triclip show it is a safe, effective option for valve repair.
Invitae has hired restructuring advisers as it explores strategic options, including a potential bankruptcy filing, the Wall Street Journal reported Monday, citing unnamed sources familiar with the matter.
The genetic testing company could file for bankruptcy within weeks, according to the Journal report.
Invitae is working to strengthen its balance sheet, and its board of directors formed a special committee focused on improving the company’s capital structure, a spokesperson told MedTech Dive
Patients with chronic back pain have traditionally received physical therapy and medication when they first present with symptoms. However, patients can stop responding to the interventions or suffer side effects and have poor long-term outcomes. The limitations of traditional options have created a need for new ways to manage low back pain, the leading cause of disability globally.
SCS is an established option for patients who continue to experience chronic back pain after surgery. The technology