Here are 7 medtech stories we missed this week but thought were still worth mentioning:
1. Corindus touts first Asian use of next-generation robot
Corindus Vascular Robotics announced in a March 31 press release that robot-assisted PCI procedures were performed for the first time in Asia using the CorPath GRX system. The procedures were performed at Fu Wai Hospital. This is the first time the system has been used outside of the U.S. CorPath GRX enhances the precision and workflow of the current CorPath system and extends the capabilities and procedures that can be robot-assisted.
2. Endologix launches stent graft study
Endologix has announced that the first patients of its Expanding Patient Applicability with Polymer Sealing Ovation Alto Stent Graft (ELEVATE) IDE clinical study have been treated, according to a March 31 press release. The purpose of the clinical trial is to test the efficiency and safety of the Ovation alto abdominal stent graft system that repairs infrarenal abdominal aortic aneurysms. The clinical trials will have 75 participants across 12 centers in the U.S.
3. NeoSurgical inks Europe distribution deal for Neoclose
NeoSurgical announced in a March 29 press release that it has signed a distribution deal with a global partner to commercialize the Neoclose in Europe. Neoclose helps surgeons close port site defects up to 3 cm after laparoscopic abdominal surgery. It uses bioabsorbable anchors and a Vector-X closure to help change port site closure.
4. Bodycad gets FDA 510(k) clearance for unicompartmental knee system
Bodycad has received FDA 510(k) clearance for its personalized Unicompartmental Knee System, according to a March 29 press release. Bodycad says it is the first Canadian company to receive FDA clearance for a joint reconstruction implant system. The Unicompartmental Knee System is designed to optimize personalized knee restoration of a patient’s unique anatomical features and kinetics. It uses 3D rendering of medical images of the patient’s anatomy.
5. Providence Medical announces 510(k) clearance and new executive management team
Providence Medical Technology received FDA 510(k) clearance for its cervical fusion device and gained two new leaders on its commercial leadership team, according to a March 29 press release. Scott Lynch is the new lead of global marketing while Michael Scott is assuming international leadership. Provience also received 510(k) clearance for its standalone use of the Cavux Cervical Cage-L system and received approval for its Ally facet screws. The Cavux Cervical Cage-L system is made of medical grade titanium and available in a variety of sizes. The Ally facet screws give stabilization as an adjunct to spinal fusion.
6. TissueTech touts Amniox study
TissueTech announced the results of its Amniox Clarix Flo for plantar fasciitis study in a March 30 press release. The study showed the benefits of the application of Amniox’s cryopreserved human umbilical cord tissue for the treatment of patients with plantar fasciitis. The study included 43 patients who received Clarix Flo injections and were monitored for 18 weeks. The results showed that pain was significantly decreased from the baseline and there was an overall functionality recovery.
7. NeoTract touts 5-year pivotal data for UroLift prostate device
NeoTract announced its 5-year follow-up data from its randomized Lift IDE study that evaluated the safety and effectiveness of the company’s UroLift system, according to a March 27 press release. The system was tested in patients who have symptomatic benign prostatic hyperplasia and showed that the treatment provided a highly tolerable, minimally invasive procedural experience; rapid reduction of symptoms after the procedure while preserving sexual function and a higher quality of life.