Ultrasound-guided laser targets Europe

Intra-Sonix of Burlington, MA, has initiated clinical trials in Germany and Belgium for itsTulip II ultrasound-guided minimally invasive surgery device.Tulip,an earlier generation product, is already approved for marketin Europe and Japan. Intra-Sonix operates a European subsidiarybased in Leuven, Belgium.

The Tulip procedure -- transurethral ultrasound-guided laser-inducedprostatectomy -- provides treatment of benign prostatic hyperplasia(BPH). Tulip II offers full 360º ultrasound viewing of theprostate along with other system upgrades. Worldwide, more thanone million men undergo surgical treatment of BPH annually, thecompany said.

Use of ultrasound imaging indicates tissue depth and anatomicalfeatures while treating BPH with laser surgery. This can helpsurgeons determine which obstructive prostate tissue to target-- and which not to target -- thus expanding the number of potentiallytreatable prostates. The laser causes necrosis of tissue, whichis subsequently sloughed off in small particles during urination.

Intra-Sonix has also initiated a new six-site U.S. clinicalstudy of Tulip, following reclassification of laser treatmentsfor BPH by the Food and Drug Administration last year. An investigationaldevice exemption application has been filed with the FDA for TulipII.