Endologix (NSDQ:ELGX) this week announced a joint R&D and exclusive distribution deal with Japan Lifeline and released case review results from the 1st-in-human use of its Ovation Alto stent graft designed for endovascular aneurysm repair.
The Irvine, Calif.-based company said it inked a deal with Japan Lifeline to jointly invest in development, clinical research and commercialization of novel endovascular stent graft systems for the treatment of thoracic aortic disease.
Japan Lifeline will gain exclusive distribution rights to the systems in Japan, while Endologix said it will commercialize the system through its existing global sales force in other regions.
“JLL is our exclusive distributor in Japan, and it has done an outstanding job supporting physicians and capturing market share in Japan with our AFX device for the treatment of abdominal aortic aneurysms. We are currently working with JLL on a full market release of our AFX2 bifurcated endograft system in Japan after receiving approval for that device earlier this year. We also anticipate Japanese market launches of Ovation and Nellix in the future. These new agreements with JLL will expand our relationship to include thoracic devices and enable us to provide a complete range of endovascular aortic devices to physicians worldwide,” Endologix CEO John McDermott said in a prepared statement.
Endologix also released data from its 1st-in-human experience from the 1st 7 patients treated with the Ovation Alto. The devices were implanted at Auckland, New Zealand’s Auckland City Hospital between Aug. 2017 and Feb. 2017.
Results from the initial cases indicated successful delivery and deployment in all patients with a 100% technical success rate. No type I or type III endoleaks, stent graft migrations, abdominal aortic aneurysm ruptures, abdominal aneurysm-related deaths or secondary interventions were reported.
“Although limited to only 7 patients, early experience with the Ovation Alto was promising and suggests the device may safely expand EVAR indications beyond that of other available devices,” Dr. Sean Lynden, who presented the results at the VIVA 2017 conference wrote in a summary.
Endologix touted that the device features a low-profile 15-F outer diameter delivery system and the ability to seal at the level of the proximal sealing ring, which is 7-mm distal to the top of the fabric.
Last month, Endologix touted results from its Leopard clinical trial, which compared its AFX and AFX2 endografts to other commercially available bifurcated aortic endografts.