eNews Nov 2, 2021The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association
Aortic stent graft is a breakthrough
An aortic stent graft system designed to treat a thoracoabdominal aortic aneurysm (TAAA) was granted breakthrough device designation by the U.S. Food and Drug Administration because it fits an unmet need. TAAA causes a dangerous bulging of the aorta extending from the chest into the abdomen. It typically involves the branch arteries that supply blood to multiple internal organs. Left untreated, the aneurysm can rupture and cause sudden death. The standard of care is complex open surgery, which is associated with a high rate of complications and mortality, and 40% of patients are not considered candidates for open surgical repair. The system was invented by Patrick Kelly, M.D., a vascular surgeon from Sanford Health, a South Dakota-based health system.
Single-use bronchoscopes reduce readmissions: Ambu
A study of 14,228 bronchoscopy procedures found sterile, disposable scopes reduced readmission rates by more than half, reports Medical Design & Outsourcing. The study, published in Chest and authored by Ambu consultant Dr. Hudson Garrett, analyzed procedures at inpatient hospitals as well as outpatient ambulatory facilities. He found that 3.6 percent of patients treated with a single-use, flexible bronchoscope were readmitted within 30 days, compared to 7.7 percent of patients whose procedures used reusable scopes.
Is it software or is it a medical device?
The FDA reportedly is close to finalizing guidance that would clarify when clinical decision support software meets the definition of a medical device and set out a risk-based framework for the software functions, reports MedTech Dive. “There is tremendous need in clarifying how the general medical device requirements apply to software,” Bradley Merrill Thompson, attorney at Epstein Becker Green, told the newsletter.
Microspheres to treat osteoarthritis
Siemens Healthineers’ Varian received FDA breakthrough device designation for its noninvasive treatment of knee osteoarthritis. Varian’s Embozene microspheres, which are already used to treat some cancers and other diseases, are injected into the artery in the knee to drive embolization. By blocking up the vessel, the microspheres are designed to reduce blood flow to the affected region and thereby limit the inflammatory process and pain. Varian acquired the technology from Boston Scientific in 2019. Building on a 40-patient study, researchers at UCLA Santa Monica are preparing to start a randomized clinical trial and a 400-patient registry. The work will advance Varian’s efforts to reach the 14 million patients with symptomatic knee osteoarthritis in the U.S.