A Medical Device Daily

As part of its push to grow its presence in the neurosurgical market, Renishaw (Wotton-under-Edge, UK) has acquired, for an unspecified cash consideration, a 75% stake in Schaerer Mayfield NeuroMate, based in Switzerland, and its wholly-owned subsidiary, Schaerer Mayfield NeuroMate Sarl (Lyon, France), a manufacturer of surgical robots for neurosurgery.

Sir David McMurtry, Renishaw's chairman and CEO, said, "This investment is an important step for Renishaw, Schaerer Mayfield NeuroMate and surgical robotics more generally. The combination of the pre-eminent stereotactic robot and the portfolio of neurological products that Renishaw is developing based on its precision engineering capabilities, will provide the neurosurgeon with the tools necessary for precise placement of current and next generation therapeutic delivery devices."

The NeuroMate image-guided surgical robot has been used to date in more than 9,000 neurosurgical procedures, including deep brain stimulation, motor cortex stimulation, stereo electro-encephalography, neuro-endoscopy, radiosurgery, biopsy, and transcranial magnetic stimulation.

It is the world's only such robot with both FDA approval and European CE mark for stereotactic neurosurgery, along with a CE mark for neuro-endoscopy applications. The robot also is approved in Japan.

Renishaw said the growth of precision-guided neurosurgery is set to drive further growth in the robot-assisted surgery market.

"As demands for increased accuracy, safety and efficiencies are required and clinical needs continue to multiply, the prospect of expanding the success of NeuroMate in France, where there is a proven installed base, to other markets, represents a great opportunity," the company said in announcing its purchase of the majority ownership share.

Renishaw said its existing neurological portfolio and investment plans in its stereotactic product line, combined with its commitment to this new technology, will enable it to shape what it termed "this significant market opportunity," providing neurosurgeons with improved clinical outcomes and overall efficiency.

The company noted that it already is involved in "cutting-edge" drug delivery activities and neurosurgical planning enhancement technologies, and the acquisition of Schaerer Mayfield NeuroMate and its robotic expertise "will provide a platform technology for these activities, advance the use of functional neurosurgical procedures and reduce clinical complication rates in existing stereotactic procedures."

Professor Steven Gill, consultant neurosurgeon at Frenchay Hospital (Bristol, UK) and an international authority in functional neurosurgery, said, "The combined capability of accurate image-guided planning and the precision delivery that the robot can provide will lead to a major advance in neurosurgery."

Renishaw specializes in the manufacture of precision metrology and inspection equipment, which is sold to a broad range of industrial sectors. In the year ended June 30, the company had revenues of £201.2 million. The Renishaw Group currently has some 50 locations in 30 countries, with more than 2,200 employees.

France sets PillCam SB reimbursement

Given Imaging (Yokneam, Israel) said the French Ministry of Health has concluded the reimbursement process for PillCam SB and set a pricing level of 418.

With that decision, Given Imaging said all of France's 64 million citizens will have reimbursable access to Pillcam SB for the following indications:

Unexplained obscure and occult GI bleeding after negative colonoscopy and EGD (upper endoscopy).

Iron deficiency anemia after negative colonoscopy and EGD.

Confirmation of suspected small bowel Crohn's disease following negative small bowel followthrough and colonoscopy

"Clinical data confirms that capsule endoscopy is the gold standard for diagnosing small bowel disorders in a non-invasive, patient-friendly manner," said Professor G rard Gay from University Hospital of Nancy. "With this decision, all French citizens will now have access to an effective diagnostic tool that can lead to improved management and outcome of intestinal diseases."

Homi Shamir, president and CEO of Given Imaging, said, "This is an important milestone for Given Imaging and we are very pleased that the French Ministry of Health has recognized the importance of capsule endoscopy for the small bowel. Today, about 235 million Europeans have reimbursed access to PillCam SB. We are working diligently to advance this process and we expect additional reimbursement decisions from other major European health ministries in the future."

The PillCam SB video capsule, which can visualize the entire small intestine, is currently marketed in the U.S. and more than 60 other countries.

Now that's a crowd!

It's an unquestioned belief that the annual MEDICA exposition in Düsseldorf, Germany, is the world's largest medical products show, but the statistics from each November's gathering are staggering nonetheless.

Staged even as a financial crisis continued to be felt worldwide, last month's concurrent staging of MEDICA and COMPAMED, the German Hospital Congress, drew 137,000 visitors, roughly the same figure as the previous year.

The event, which pretty much makes a mockery of the adjective "sprawling," drew 4,313 exhibitors from 67 countries.

Messe Düsseldorf, the sponsor of the annual extravaganza, said those exhibitors presented "the complete spectrum of new products, services and processes for use in physicians' offices and hospitals."

Just under 40% of the attendees came from countries other than Germany. On the exhibitor side, 70% of the companies were from outside of Germany. The leading international exhibitor nations were China (377 companies), the U.S. (355), Italy (332), Great Britain (246) and France (210).

For those who want to look ahead, the dates for the next MEDICA staging are Nov. 18-21, 2009.