FDA Gives CryoCor the Cold Shoulder

San Diego-based CryoCor suffered a blow today, when it learned that FDA is yet again unhappy with the company’s pre-market approval application for its Cryoblation System, which uses extreme cold to treat cardiac arrhythmias. The news came two days before CryoCor was scheduled to present clinical data at an FDA advisory panel meeting.

CryoCor is seeking an approval for atrial flutter, a condition where the upper chambers of the heart beat too fast. Unlike other devices on the market that use heat to treat atrial flutter, the Cryoablation System uses extreme cold to destroy damaged cardiac tissue. Watch this video to see how it works. (And read here about another company that recently sunk money into cryoenergy devices.)

As of last week, system’s were a go, with CryoCor issuing a press release to remind investors that the PMA meeting was on track. But on Monday, FDA said it was not convinced that the device is effective long-term. According to the Associated Press, “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.”

And the AP reports that “more than six percent of patients” in CryoCor’s study experienced adverse events after being treated with the Cryoablation System.

This is the second time FDA has found fault with CryoCor’s device. Last year it rejected the company’s PMA application, prompting CryoCor to amend and resubmit in November 2006.

The Cryoablation System has been on the market in Europe since 2002 for atrial fibrillation and atrial flutter. In April, CryoCor raised $5.45 million in a private placement with a group of accredited investors.

  1. FDA Okays CryoCor’s Atrial-Flutter Device : OneMedPlace

    on August 2, 2007

    […] comes after a somewhat tumultuous wait. In June, the company learned that an FDA advisory panel was not convinced of the Cryoablation System’s longterm efficacy or safety profile, only to find out two days […]

  2. Louise Snyder

    on February 13, 2008

    Here, I was happy to hear a bout this Cryoablation System as beta blockers are not always good at containing Artrial Fibrillation.Now the FDA vetoed this. The regualar pace makers only help very low pulses. I heard recently on Channel 8 in Las Vegas that it does help and hopefully control these awful flutters and irregular heart beats. My Cariologist wants me on a pacemaker. I dont have slow pulse rate, so what good is a regular pacemaker. Could Artrial Fibrillation come from a low CBC red blood count? Thank you Louise Snyder

  3. OneMedPlace » Blog Archive » Boston Scientific to Acquire CryoCor

    on April 18, 2008

    […] CryoCor suffered a blow in June when it learned that FDA was unhappy with its pre-market approval (PMA) application for its Cryoablation System, which uses extreme cold to treat cardiac arrhythmias. It was the second time the FDA has found fault with the company’s device. In 2006, the FDA rejected the CryoCor’s PMA application, prompting the company to amend and resubmit in November 2006. […]

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