Medtronic, Inc. MDT announced yesterday afternoon FDA approval for its Protecta XT ICD and CRT-D platform with shock-reduction capabilities, Oppenheimer reports.
“The FDA nod follows the March 9 resolution of MDT's Mounds View, MN warning letter; the Protecta had been originally slated for 2H10 US release prior to the Mounds View delay,” Oppenheimer writes. “The Protecta's SmartShock technology includes six new MDT-exclusive algorithms designed to deliver therapeutic shocks only when appropriate, thereby improving patient quality of life.
“With its demonstrated 98% of patients free from inappropriate shocks at 1-year (92% free at five years), we believe Protecta can help offset pricing pressure and drive share wins. Shipments of Protecta XT products will commence immediately.”
Medtronic closed Monday at $38.85.
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