A Diagnostics & Imaging Week

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 follow through 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.

CE mark for automated Lp-PLA2 test

diaDexus (South San Francisco, California), reported that it received CE Mark approval for the automated format of the PLAC Test for Lp-PLA2. This automated format of the PLAC Test, capable of running on a wide range of clinical chemistry analyzers, received FDA clearance in December 2007.

diaDexus also reported the first shipment of the CE-marked PLAC Test to Europe.

The company said the PLAC Test is the only blood test cleared by the FDA to assess risk for both coronary heart disease and ischemic stroke associated with atherosclerosis. The test measures lipoprotein-associated phospholipase A2 (Lp-PLA2), a vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque. It is plaque rupture and thrombosis, not stenosis, that cause the majority of cardiac events. Clinical research demonstrates that early diagnosis of cardiovascular disease improves the likelihood of preventing these events.

President/CEO Patrick Plewman said, "Over 2 million people in the 27 EU member states die of cardiovascular disease each year; heart disease is the leading cause of death, and stroke is third. Working closely with our distribution partners in the EU, diaDexus is committed to expanding access to the PLAC Test in Europe to help identify individuals at increased risk of suffering a heart attack or stroke."

Wolfgang Koenig, MD, of the University of Ulm (Ulm, Germany), said, "It is well documented that traditional risk factors fail to identify many people at risk for developing cardiovascular disease. The PLAC Test provides us with information we've never had before about a patient's risk for coronary heart disease and ischemic stroke, helping to determine the best course of treatment to prevent these events from occurring."

He added, "Lp-PLA2 has similar predictive power for both primary coronary heart disease in initially healthy subjects, as well as for recurrent events in those with clinically manifest atherosclerosis."

Italian hospital orders Mobetron

IntraOp Medical (Sunnyvale, California) reported that it has received an order for its Mobetron radiation therapy device from Azienda Ospedaliero-Universitaria Ospedali Riuniti Trieste in Northern Italy.

The Mobetron is a mobile device that delivers intraoperative electron-beam radiation therapy (IOERT) to a tumor site during cancer surgery. The Mobetron enables radiation and surgical oncologists to target the exact area that requires radiation and to deliver an effective dose of radiation directly to the affected tissue during surgery.

Since the Mobetron is a mobile, self-shielded device, doctors will be able to move the Mobetron between operating rooms, avoiding the high cost of outfitting radiation rooms to accommodate traditional linear accelerators. Ospedali Riuniti will use the Mobetron to treat many forms of cancer but have acquired the device to specifically expand their treatment for breast cancer.

The radiotherapy facility at Ospedali Riuniti has been treating patients for more than 40 years and has been a leader in implementing new technology for the treatment of cancer. The radiotherapy department currently treats 1,000 patients a year.

Ospedali Riuniti will join a regional program with Centro di Riferimento Oncologico (CRO) in Aviano, Italy, to provide the best cancer treatment possible to the region. CRO adopted the Mobetron in 2007 and is one of the few hospitals in Italy that has been given the status of Institute for Research in the Cure of Cancer and Scientific Study.