In Brief: Medtronic
This article was originally published in The Gray Sheet
Executive Summary
Medtronic: Rolls out four Thera-i pacemakers in the U.S. following PMA supplement approval by FDA on Nov. 6. The next-generation Thera devices offer about 30% longer service life and a more oval, "easier-to-implant" shape than the original Thera line, which remains on the market. Medtronic began marketing the Thera-i line in Europe in August. The devices sell at about a $200 premium to the earlier generation Thera pacemakers and range in price from $5,800 for the single chamber pulse generator and $6,500 for the single chamber rate responsive device to $7,000 for the dual chamber device and $7,500 for the dual chamber rate responsive device. The dual chamber models also have enhanced sensing and programming capabilities, the firm notes. Medtronic also announces release of its Model 5348 temporary pacemaker for critical care following marketing go-ahead from FDA...
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