The funds will support regulatory activities and the planned 510(k) submission for approval to the U.S. Food and Drug Administration (FDA) for Flexi-Port â„¢ SLF-TANL â„¢, a novel subcutaneous port ...
The ThecaFlex DRx System (ThecaFlex), a technology within Alcyone's Falconâ„¢ Delivery Platform, is an implantable intrathecal (IT) catheter, catheter fixation device, and subcutaneous port system ...
A novel indwelling subcutaneous intrathecal catheter circumvented the complex spine anatomy of patients with spinal muscular atrophy (SMA), a challenge when giving nusinersen via intrathecal injection ...