A Medical Device Daily

In a move that may not bode well for the company, the FDA said yesterday that a CryoCor (San Diego) device that uses extreme cold to treat defective heart muscle did not show overwhelmingly safe or effective results in company studies.

The agency posted its review of the company’s Cryoablation system to its website ahead of a Wednesday meeting where outside experts will vote on whether the device should be approved by the FDA. The agency does not have to follow the panel’s recommendation, though it usually does.

On the news ahead of its panel meeting, shares of CryoCor plunged $1.63, or 37%, to $2.77.The company has asked FDA to approve the device to treat atrial flutter, a condition where the upper chambers of the heart do not pump in-synch with the lower chambers.

Federal reviewers said that CryoCor’s device stopped uncoordinated heart pumping immediately after use in a significant number of patients. But after six months follow-up, company studies failed to show that the device stopped the condition from recurring in a significant number of patients.

The company’s Cryoblation system uses a catheter to deliver freezing cold temperatures that isolate damaged tissue in the upper chambers of the heart, with the goal of restoring normal pumping action. CryoCor argues that the freezing technique is safer than a heat-based system.

But FDA staff said that more than 6% of patients treated with device experienced an adverse event, higher than the company’s target.

The device met its goal of “acute” effectiveness, in which the procedure restores normal heart rhythm.

CryoCor CFO Gregory Tibbitts told Reuters that he expected the panel to focus on the device’s overall effectiveness at curing atrial flutter. Its safety data are comparable with other ablation devices and therefore should not be a hurdle, he said.

“We believe the FDA will be asking the question of the group of physicians on Wednesday: Is 81.6% a good enough cure rate to warrant approval?” Tibbitts said in an interview. “Obviously we believe it does.”

Tibbitts said he was surprised by the stock’s decline in the wake of the FDA posting, because the company had previously disclosed the safety and effectiveness data in a regulatory filing.

Matt Dolan, analyst at Roth Capital Partners, said the FDA staff report highlights already-published data with little hint of which way the agency may lean.

“We think today’s trading is a reaction to an FDA executive summary that really frames what will be discussed at Wednesday’s advisory committee meeting but does not draw any definitive conclusions as to whether there will be a positive or negative recommendation for the company,” said Dolan.

The FDA’s negative review comes after the agency rejected the company’s application last year (Medical Device Daily, Feb. 6, 2006), saying it did not show a high enough success rate in clinical trials to warrant approval. Later in the year CryoCor submitted additional data from ongoing studies and had been told in February that it did not believe it would need to convene an advisory panel meeting for the company’s premarket approval for this application, only to be told in April that it would have to go before the panel.

CryoCor is also conducting a Phase III study of its device to treat atrial fibrillation, another type of errant heart rhythm. Tibbitts said the company expected that trial to finish in three months, and it hoped to submit its application to market the treatment in the second half of 2008.