Dante J. Pieramici, M.D., of the California Retina Research Foundation, explains changes made to the Susvimo port delivery system that are designed. to prevent the septum dislodgment that led to Genentech pulling the product off the market.
In an interview with Managed Healthcare Executive, Dante J. Pieramici, M.D., summarizes his presentation at the American Society of Retinal Specialists meeting last week in Stockholm, Sweden about changes made to the Susvimo port delivery system.
Genentech pulled Susvimo off the market in October 2022 after the valve-like septum that receives the needle used to refill the device with ranibizumab became dislodged in 5% of patients. With the FDA's approval, Genentech put the reengineered Susvimo back on the market earlier this month.
Pieramici, a Genentech consultant who is co-director of the California Retina Research Foundation and a partner of California Retina Consultants, explained that the geometry of the septum has been altered and the glueing procedure changed to tighten the bond between the septum and the rest of the device. In additon, the needle used to refill the delivery has been modified with a silicone lubricant so it goes into the septum with less force.
Pieramici said that in vitro testing of the new version of the port delivery system showed no failures in a model that was the equivalent to Susvimo being in a person's eye for 30 years. In vitro testing of the prior version showed 50% of the implants failed after 10 years, according to Pieramici, The changes to Susvimo mean "patients and physicians can be comfortable that this septum dislodgment is not going to occur in the future. They have solved the problem," Pieramici said.
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