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Thursday, Oct 10
CardioMEMS heart failure device gets FDA panel split decision
- An FDA advisory panel sent a mixed message yesterday about the CardioMEMS Champion HF Pressure Measurement System, sending shares of St. Jude Medical (STJ -2.5%), part owner of CardioMEMS, lower.
- Champion HF is an implantable device provides that provides daily pulmonary artery pressure measurements to guide physicians in their treatment of patients with congestive heart failure.
- One panel member said it was impossible for the members to tie the daily measurements of the pulmonary artery to a decrease in hospitalizations or other important clinical outcomes; “We couldn’t connect the dots."