Minnesota Medical Development's Rebound HRD:
This article was originally published in Clinica
Executive Summary
The Rebound HRD hernia repair device developed by Minnesota Medical Development has been granted 510(k) clearance by the US FDA. The Rebound HRD is a self-expanding surgical mesh device composed of Nitinol, designed for the laparoscopic repair and/or reinforcement of both inguinal and ventral hernias. It conforms to the anatomy while providing stability, eliminating the need for anchoring, which, in turn, minimises patient post-op discomfort and the risk of nerve/blood vessel injury. It can also be used for other soft tissue defects where weakness exists and where the support of a non-absorbable material is preferred. The Plymouth, Minnesota company CE-marked the product for sale in the EU in June (see Clinica No 1261, p 22).
You may also be interested in...
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.
Lilly Can Rest Easy As Tirzepatide Scores Phase III Sleep Apnea Win
Topline results from two studies in obstructive sleep apnea among obese adults showed efficacy crossing the 50% threshold that physicians have called clinically meaningful.