Austin, Texas-based Apollo Endosurgery Inc. reported that the U.S. FDA has completed the review of the final post-approval study (PAS) report for the Orbera intragastric balloon system and accepted that all post-approval study requirements have been fulfilled. The study was a requirement following the FDA's approval of Orbera in August of 2015. The study was a multi-center, open label, prospective study with a primary safety endpoint and its secondary endpoint being effectiveness. All study endpoints were successfully met, the company said. There were no instances of death, gastric perforation, bowel obstruction or acute pancreatitis. The most common serious adverse events were nausea and vomiting, which tended to resolve within the first month after placement.
Atricure Inc., of Mason, Ohio, reported that results from the CONVERGE IDE trial have been accepted for presentation in the late-breaking abstract sessions at the Heart Rhythm Society scientific sessions. The abstract will be presented as a webinar on Heart Rhythm 365, the society’s digital information platform. Specific details on the exact timing of the presentation will follow in a separate announcement. The CONVERGE IDE trial is a landmark prospective, randomized trial comparing the Convergent approach to endocardial catheter ablation for patients with persistent or long-standing persistent atrial fibrillation. The Convergent approach is a multi-disciplinary therapy in which a closed chest epicardial ablation is performed by a surgeon, and then complemented by an endocardial catheter ablation performed by an electrophysiologist. Patients were enrolled at 25 sites across the U.S., along with two sites in the U.K.
Paris-based Eos imaging SA, a maker of 2D/3D orthopedic medical imaging and software solutions for 3D anatomical modeling and surgical planning reported it has rescheduled the publication of its results for the full year ended Dec 31, 2019. The new publication date for its results will be April 27, 2020.
Kolon Tissuegene Inc., of Rockville, Md., said it plans to restart its phase III study of TG-C, a first-in-class cell and gene therapy targeting osteoarthritis of the knee and begin enrolling new patients later this year, following the April 10 lifting of an FDA clinical hold. Two pivotal phase III trials for U.S. approval of TG-C will enroll close to 1,020 patients at more than 50 centers across the U.S.
Brooklyn Park, Minn.-based Piranha Medical LLC, a company with innovative catheter solutions in the gastrointestinal, pulmonary, and pancreatic markets, reported the release of its newest product, Piranha LC. The Piranha LC (Luminal Clearance) is a catheter-based device that has proven to be successful as an alternative methodology for the removal of mucus and lung lavage in severe COVID-19 patients. The Piranha LC has provided an alternative treatment option for COVID-19 patients who require the removal of mucus and lung lavage for both testing and disease recovery purposes. The Piranha LC offers a safer alternative than the current practice by enabling the deep mucus removal and lung lavage without aerosol generations using a patented filtered aspiration system, independent of a bronchoscope. This system enables a suitable intervention for ventilated patients without spreading the virus. The new use allows for the proper sampling of non-contaminated lung samples, which could not previously be performed.
Pluristem Therapeutics Inc., of Haifa, Israel, said it treated its first U.S.-based COVID-19 patient under the U.S. FDA’s Single Patient Expanded Access Program, part of the U.S. Coronavirus Treatment Acceleration Program. The patient was treated with Plx (placental expanded) cell therapy at Holy Name Medical Center in New Jersey, an acute care facility currently active in Pluristem’s Phase III critical limb ischemia study.
Salt Lake City-based Predictive Biotech, a wholly owned subsidiary of Predictive Technology Group, has applied to the U.S. FDA for emergency use authorization for mesenchymal stem cells (MSCs) derived from umbilical cord tissue for the treatment of acute respiratory distress syndrome (ARDS), secondary to SARS-CoV-2, the coronavirus that causes COVID-19. A proposed IND trial will utilize Predictive’s core technology of naturally occurring MSCs from umbilical cord tissues to assess its efficacy as an add-on therapy to standard treatment of patients with COVID-19-related ARDS.
New York-based Scworx Corp. reported the first installment of a purchase order for 48 million COVID-19 rapid test kits from Rethink My Healthcare, a virtual health care network. The order calls for 2 million units for 24 weeks at a value of $35 million per week.
Santa Clara, Calif.-based Shockwave Medical Inc. has completed enrollment in the DISRUPT CAD IV coronary intravascular lithotripsy (IVL) clinical trial. The prospective, multicenter, single-arm confirmatory study of 64 patients at eight sites across Japan is intended to support regulatory approval of the Shockwave Coronary IVL System and Shockwave C2 IVL Catheter in Japan.
Staar Surgical Co., of Lake Forest, Calif., has withdrawn its fiscal 2020 guidance, due to uncertainties stemming from the COVID-19 pandemic. The company noted a “substantial slowdown” in sales in global hotspots for the novel coronavirus, and said that slowdown is expected to to continue and even pause as elective surgeries are delayed to address COVID-19 needs.