St. Jude Medical’s single-connector lead is approved
This article was originally published in The Gray Sheet
Executive SummaryFDA approves the first "four-pole" defibrillator connector system, allowing a single connection between a cardiac resynchronization therapy defibrillator (CRT-D) and its leads with one set screw, St. Jude announces Feb. 5. Traditional lead designs require three connections and four set screws. The new connector, known as IS-4 and also being developed by Medtronic and Boston Scientific, is meant to simplify surgical placement and provide a smaller product. St. Jude's "SJ4" system uses a Durata defibrillation lead and Promote CRT-D with SJ4 connectors. The firm will conduct a five-year post-approval study with up to 1,700 patients and gather additional data through its SCORE patient registry. Critics have called for greater pre-market human testing of such innovative lead designs for the sake of patient safety (1"The Gray Sheet" Dec. 15, 2008, p. 7)
You may also be interested in...
Once a pariah because of its price-gouging, the new approval represents a change of tack from Horizon.
Erik Hansson remains deputy head of devices in a move to the European Commission’s DG Sante from DG Grow. He now answers to a newly appointed devices head who shares a common educational background but whose recent pharmaceutical role may unsettle the devices industry.