Integer, a leading medical device outsource manufacturer, has entered into a new development agreement and a new supply agreement with Respicardia Inc. Under the agreements, Integer will be Respicardia’s development partner and majority supplier of the remedē implantable pulse generator (IPG) and related products for 7 years, the first 5 ½ years as an exclusive supplier.
“We’re honored to continue supporting Respicardia in bringing their therapy to market,” says Tony Gonzalez, president of Integer’s Cardiac Rhythm Management and Neuromodulation product line, in a release. “We supported their initial system development as they worked through their clinical studies, so it’s exciting to see their transition to commercialization. These agreements highlight Integer’s breadth of capabilities to support customers with design, development, and manufacturing of custom IPG systems. Our end-to-end expertise will help Respicardia ensure the utmost quality and reliability of their products.”
Peter Sommerness, president and CEO of Respicardia, says, “In product innovation, quality, and uncompromising clinical performance, Integer-manufactured devices are second-to-none. Integer is recognized as an innovative company that shares our vision to improve patient quality of life and overall health. Respicardia sought a partner with the ability to scale the production to meet the market needs of our unique therapies.”
Respicardia’s remedē System is a transvenous neurostimulation device that treats moderate to severe central sleep apnea in adult patients. CSA results from the brain’s failure to send appropriate signals to the respiratory muscles to stimulate breathing.
from Sleep Review http://www.sleepreviewmag.com/2019/01/integer-respicardia-commercialization-central-sleep-apnea-market-new-agreements/…