Bioventrix said today it won FDA investigational device exemption approval to initiate a pivotal trial of its Revivent TC transcatheter ventricular enhancement system device designed for reshaping and restoring the left ventricle. Revivent is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart. Instead, the transcatheter procedure enables placement of small […]
Clinical Trials
Pixium wins UK nod for Iris II ‘bionic eye’ trial
French retinal implant maker Pixium Vision said today it won U.K. Medicines & Healthcare products Regulatory Agency approval to initiate a clinical trial of its Iris II bionic vision system designed to restore sight to patients with retinitis pigmentosa. The Iris system is comprised of a retinal implant and a pair of camera-mounted glasses connected to a […]
Centerline Biomedical wraps up pre-clinical study, looks to Series A
Interventional vascular device-focused Centerline Biomedical said today it completed its 1st pre-clinical study evaluating its IOPS endovascular navigation technology and is looking towards a Series-A round of financing to support the device. The system, based on research from the Cleveland Clinic’s Heart & Vascular Institute, is designed to aid surgeons navigating endovascular aneurism repair procedures, with […]
Celgene inks collab deal with EMR firm Trinetx
Celgene (NSDQ:CELG) said today it inked a collaborative deal with TriNetX to develop advanced clinical trial design for Celgene’s next-gen therapeutic programs. Through the deal, Celgene will be able to access medical data from electronic medical records through TriNetX’s proprietary network of healthcare institutions, the companies said. “TriNetX represents the future of a data-driven approach to […]
Titan Medical extends Asia Pacific exclusive distro negotiation, initiates usability studies
Titan Medical (CVE:TMD) said today it inked a 3-month extension on negotiations with Longtai Medical to distribute its Sport surgical robot in the Asia Pacific region and it initiated usability studies for its Sport system to comply with newly published FDA guidance. The company said it extended the negotiation of exclusive rights for distribution in the […]
Diabetes experts: Bariatric surgery should be the standard of care
Diabetes experts from a consortium of medical societies and organizations say bariatric surgery should be a standard treatment for patients with the condition, as it offers potential control of diabetes for years without medication. In a joint statement, the 45-member group said bariatric surgery could have a significant benefit for thousands of patients, calling the move […]
GI Windows releases 6-month data on self-assembling magnet diabetes device
GI Windows said 6-month data from a small study of its incisionless anastomosis system showed the safety and efficacy of the device, which uses self-assembling magnets delivered via endoscope to create an opening between loops of the small bowel. West Bridgwater, Mass.-based GI Windows said the device is designed to allow a portion of ingested food […]
New GI Dynamics CEO Schorer looks to reboot EndoBarrier
New GI Dynamics (ASX:GID) CEO Scott Schorer is looking to reboot the company’s flagship EndoBarrier weight loss device, after a higher-than-expected rate of liver abscesses forced the halt of a clinical trial last year. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and […]
Providence Medical touts 2-year cervical fusion data, $2.9m funding round
Cervical spine-focused Providence Medical last week released 2-year radiographic and clinical outcomes from a study of its DTrax system of instruments and implants and announced a $2.8 million round of equity financing. Results from the single-arm, multi-center study were presented at the Spine Week 2016 conference in Singapore last week, the Walnut Creek, Calif.-based company said. “The […]
Gordian Surgical launches 1st-in-human trials of TroClose 1200
Trendlines Medical portfolio company Gordian Surgical said today it launched 1st-in-human trials with its TroClose 1200 trocar designed to enable access to the abdomen during laparoscopic surgery, as well as closing the access through suturing incisions in the abdominal wall. The Israel-based company’s TroClose 1200 is designed to be used to open the abdomen and insert […]
Baxter touts data on Theranova Dialyser efficacy, toxin clearance
Baxter (NYSE:BAX) today presented data from 24 different abstracts on treatments for end-stage kidney disease, touting 8 that covered its Theranova dialyser, indicated for treating chronic and acute renal failure. The study data was presented at the European Renal Association and European Dialysis and Transplant Association’s 53rd Congress this week. ”Regardless of where dialysis therapy is performed […]