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."
St. Jude Medical (STJ +3.4%) rises to an all-time high on heavy volume.
Briefing documents from the FDA regarding an advisory panel meeting for CardioMEMS' Champion Heart Failure Monitoring System seem to suggest the regulator is more likely to approve the device this time around — or at least that's RBC and Leerink's reading. (full briefing documents)
"We think there's a few clauses in the conclusion where the FDA reviewers portray subtle inclinations," RBC's Glenn Novarro says.
Meanwhile, Leerink's Danielle Antalffy is already looking forward to an STJ deal for CardioMEMS: "We estimate [Champion HF] can ultimately contribute an incremental $0.25-$0.50 in EPS." (IBD)
St. Jude Medical (STJ +0.6%) says it received CE Mark approval of its next-generation EnligHTN Renal Denervation System for treating patients with drug-resistant, uncontrolled hypertension.
The system features an advanced generator that delivers simultaneous ablations via a multi-electrode catheter, reducing total ablation time by more than 80% in comparison to the first generation system, from approximately 24 minutes to four minutes.
The new system will be on display during the 2013 European Society of Cardiology meeting from August 31 to September 3.
St. Jude Medical (STJ) has bought Swiss-based Endosense for an initial $170M and up to $161M in milestone payments.
Endosense develops TactiCath, which allows physicians to monitor the amount of force they apply to the heart wall during a catheter ablation procedure to remove or stop a faulty electrical pathway.
"Force sensing is a tremendous advancement in cardiac ablation that will potentially improve safety and efficacy, likely becoming a standard for all cardiac ablations," says Dr Vivek Reddy of Mount Sinai Hospital in New York. (PR)
More on St. Jude Medical (STJ +2.1%) Q2: net profit -53% to $115M, hurt by charges of $160M, primarily related to debt retirement. Adjusted net profit flat at $275M. Net sales also flat. Sales breakdown: Cardiac Rhythm Management -4% to $718M; Atrial Fibrillation +9% to $237M; Cardiovascular flat at $340M; neuromodulation +2% to $108M. Guidance: Q3 EPS of $0.88-0.90 vs consensus of $0.88; FY EPS of $3.70-3.73, increasing the lower range by $0.02 from prior forecast and vs analyst predictions of $3.69. (PR)
Deutsche Bank (Buy) thinks the approval of St. Jude Medical's (STJ +2.6%) implantable cardioverter and cardiac resynchronization defibrillators is a "good sign," as it may signal that STJ is "making progress" with its efforts to allay concerns tied to an FDA inspection of the company's Sylmar, California manufacturing facility. Wedbush's Tao Levy concurs, noting that the FDA "viewed the safety enhancements of the Ellipse and Assura as important enough to approve despite the warning letter."
St. Jude Medical, Inc., develops, manufactures and distributes cardiovascular medical devices for global cardiac rhythm management, cardiovascular, atrial fibrillation therapy areas and neurostimulation medical devices for the management of chronic pain.