FDA clears SonaCare HIFU prostate device, prompts Edap to yank de novo, go for 510k

SonaCare said it won FDA pre market approval for its high intensity focused ultrasound device designed to treat prostate cancer, causing competitor EDAP (NSDQ:EDAP) to yank the de novo application for its Ablatherm HIFU.

SonaCare said its Sonablate 450 will be available in the U.S. this October.

“The FDA regulatory authorization to market Sonablate in the U.S. is a milestone for non-invasive prostate care and a tremendous gain for men’s health. Men all over the world, in the more than 49 countries where it has already been authorized for use, have had access to this technology for prostate ablation. There are numerous peer reviewed articles attesting to its value in ablating the prostate while minimizing the occurrence of side effects. Our company is appreciative of the collaborative efforts made on the part of the FDA to bring this technology to the U.S.,” SonaCare CEO Dr.Mark Carol said in a press release.

The Sonablate is SonaCare’s 2nd medical device to win clearance, having won 510(k) clearance for its Sonatherm laparoscopic high intensity therapeutic ablation device.

“With the authorization to sell Sonablate in the U.S., we can now offer a full HIFU surgical suite of technologies working off of the same basic platform and providing benefits throughout health care centers,” Carol said in prepared remarks.

The approval caused therapeutic ultrasound company EDAP to withdraw the de novo application for its Ablatherm device to piggy back on SonaCare’s clearance and seek 510(k) instead.

“This development is a significant step forward for HIFU technology and the U.S. urology community as a whole. EDAP, being the world leader in HIFU in Urology, believes that the FDA’s approval of HIFU technology for prostatic tissue ablation with a predicate device is a crucial milestone in the recognition and establishment of HIFU as a standard of care tool in prostate tissue ablation in the U.S. and Worldwide. Our path to market in the U.S. is now clearer than ever, as we can now obtain clearance via a more straightforward 510(k) pathway by demonstrating that Ablatherm is substantially equivalent to the predicate device, without the need to pursue a de novo pathway,” EDAP CEO Marc Oczachowski said in a press release.

Last October, an FDA panel failed to recomend approval for SonaCare’s Sonablate, causing the company to reposition it to treat more aggressive stages of prostate cancer.

The FDA’s Gastroenterology & Urology Devices panel voted 7-3 with 1 abstention that the SonaCare device is not safe for the proposed indication to treat “biopsy proven recurrent prostate cancer, stage T1c – T2, in patients who have failed primary External Beam Radiation Therapy and have a PSA ≤ 10 ng/mL. The panel voted 9-2 with no abstentions that the device is effective and 10-0 with 1 abstention that its benefits outweigh its risks.

The company said several panel members suggested the potential value of the Sonablate technology in treating a subset of patients with radiorecurrent prostate cancer who have a Gleason score greater than 6, a more aggressive stage of the condition.

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