Clarus Medical Systems Received FDA Clearance on SITEtrac System.

MINNEAPOLIS--(BUSINESS WIRE)--Sept. 1, 1998--Clarus Medical Systems, Inc., a world leader in spinal endoscopy, today announced FDA clearance of its SITEtrac(TM) spinal surgery system. Clarus' SITEtrac system significantly advances the evolution of minimally invasive surgery. SITEtrac offers surgeons an alternative to traditional, open, lumbar spine surgery. The SITEtrac system of tubular dilators and retractors, along with the SITEtrac high-resolution endoscope, provides surgeons with the ability to perform minimally invasive surgery requiring an incision as small as a puncture wound. Unlike other spine surgery systems, the SITEtrac system does not require specialized instrumentation and it is reusable. Both these features greatly enhance cost effectiveness.

The soon-to-be-released SITEtrac System joins Clarus' other spinal products including SITEprobe(TM), an easy-to-use, low-cost diagnostic endoscopy system; PercScope(TM), a percutaneous discectomy system which provides endoscopic visualization, suction, flush and an integrated 2 or 3 mm working channel; SpineScope(TM), allowing percutaneous sacral access to the lumbar epidural space and; LASE(TM), a percutaneous disc decompression system which integrates laser, imaging and irrigation in one small catheter. Clarus' spinal product families permit endoscopic surgery which offers minimal trauma and accelerated recovery to surgery patients. In addition to being cost effective and offering accelerated recovery, endoscopy often allows surgical intervention for patients that may not be considered candidates for traditional surgery due to age or health conditions.

"This SITEtrac clearance completes our next generation of reusable endoscopic spinal products. We now have less-invasive products available for all aspects of lumbar spine surgery," says Tom Barthel, President and CEO of Clarus. "Although our primary focus is the spine, we do collaborate with medical device manufacturers in a number of surgical areas to promote the development of minimally invasive medical devices. Our patents and FDA clearances cover a wide range of surgical applications enabling us to extend our expertise into these other fields," continued Barthel.

Clarus' reputation for high standards and innovation in small fiber endoscopy became widely known in the field of intracranial neurosurgery. In 1997, Clarus negotiated a licensing agreement with Medtronic for the intracranial product line. Clarus applied the funds generated from that transaction to build this next generation of spinal endoscopy products enabling Clarus to introduce endoscopic systems that can be used in virtually all of the spinal surgeries performed in the US. "We are well on our way to achieving our goal of becoming The Spinal Endoscopy Company," says Barthel.

    CONTACT: Tom Barthel, President and CEO
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