The Toronto-based company’s system allows for a minimally invasive, whole-gland ablation of the prostate, guided by magnetic resonance imaging machines, the company said.
“Our innovation and passion for this unique therapy has been recognized with the achievement of CE Mark. This is a major step forward in the growth of the company, facilitating the commercial launch of Tulsa-Pro in Europe and other CE Mark jurisdictions. We expect this approval to be a catalyst for the adoption of our therapy, which has the potential to make a significant impact on the clinical community and, ultimately, patients being treated with Tulsa-Pro,” CEO Steve Plymale said in a press release.
The Tulsa-Pro device uses MRI imaging and transurethral robotically-driven ultrasound and closed-loop thermal feedback control to provide highly precise treatment tailed to a patient’s anatomy and pathology, the company said.
“MRI-guided Tulsa-Pro is excellent for planning, guiding and monitoring focal prostate cancer treatment in order to maximize the therapeutic effect and avoid adverse effects. Obtaining a CE Mark for Tulsa-Pro is an important step forward to broaden the therapeutic offering for localized prostate cancer,” Phase I clinical trial lead researcher Dr. Boris Hadaschik said in a prepared statement.
Last July, Royal Philips (NYSE:PHG) said it signed a deal with Profound Medical to use Profound’s proprietary transurethral ultrasound ablation technology to treat prostate cancer patients in conjunction with Philips’ Ingenia and Achieva 3 tesla MRI systems.
The treatment requires only a single session and has comparable outcomes to the best alternative treatment options, the companies said.
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