A Medical Device Daily

Cardima (Fremont, California), a device company focused on the treatment of atrial fibrillation (AF) and manufacturer of the Cardima Surgical Ablation System, reported receiving CE-mark approval for its surgical ablation probe with stabilization sheath. All components of the Cardima surgical ablation system are now approved for marketing. The system can be used in open-chest surgery in conjunction with other procedures, or as a thoroscopic stand-alone, closed-chest procedure.

"Our discussions with European thought leaders cause us to believe there is a tremendous opportunity in Europe for the Cardima surgical ablation system for cardiac ablation procedures," said Robert Cheney, CEO of Cardima. "Our system has patented technology that allows for creating deep, long, linear and transmural cardiac lesions. Additionally, our system treats both the left and right atria, which we believe is necessary for the successful treatment of arrhythmias."

The surgical ablation probe with stabilization sheath is a microcatheter-based surgical probe powered by the company's Intellitemp radio frequency (RF) energy management device. Together these components comprise the Cardima surgical ablation system. The Surgical Ablation Probe allows for creation of cardiac lesions without gaps through the use of RF and Intellitemp's "controlled RF" technology. The probe's small, flexible design offers sole port-hole access and incorporates irrigation, suction and illumination, which aid in placement and lesion depth.

Misonix in distribution for Belgium/Luxemburg

Misonix (Farmingdale, New York), a developer of minimally invasive ultrasonic device technology, which in Europe is used for the ablation of tumors and worldwide for other acute health conditions, has entered into a new, three-year, exclusive distribution agreement with Sophysa Benelux (Braine l'Alleud, Belgium) for the distribution of the SonaStar ultrasonic surgical aspirator and the BoneScalpel ultrasonic bone cutter.

The agreement provides Sophysa with the rights to sell in Belgium and Luxembourg, and includes minimum purchase requirements.

The SonaStar is used by neuro and general surgeons for quick and efficient removal of both hard and soft tumors while sparing most vessels. In addition, OsteoSculpt bone shaving technology can be employed with the SonaStar to safely remove osseous structures, thus providing access to the surgical site.

The BoneScalpel is a tissue specific osteotomy device capable of making precise cuts through bone and hard tissue while largely preserving delicate soft tissue structures.

Roche LightCycler test for MRSA garners CE mark

Roche (Basel, Switzerland) reported receiving the CE mark for its new LightCycler test for the detection of methicillin-resistant Staphylococcus aureus (MRSA).

The LightCycler MRSA Advanced Test is a qualitative in vitro diagnostic test for the direct detection of nasal colonization with MRSA.

"As more guidelines recommend or require aggressive screening, it is important that healthcare professionals have access to fast, reliable products that can help improve medical outcomes," said Daniel O'Day, head of Roche Molecular Diagnostics. "This new test will aid infection control programs, and ultimately result in better patient care."

Healthcare-associated infections caused by MRSA have recently become an important issue for healthcare facilities worldwide due to high rates of infection, mortality, and high costs of treatment. In addition, community-associated MRSA (CA-MRSA) has spread in the past few years, feeding the pipeline of infection in hospitals, and underscoring the need for comprehensive infection control programs.

The LightCycler MRSA Advanced Test is performed on Roche's LightCycler 2.0 Instrument with nasal swab specimens from patients suspected of colonization, using Roche's patented real-time polymerase chain reaction technology.

Veeva launches operations in Europe

On the heels of a corporate name change Veeva Systems (Pleasanton, California), formerly Verticals onDemand, reported the launch of operations in Europe. The company has opened an office in Stockholm, Sweden that will be managed by Peter Nordblad, Veeva's new EMEA director of sales. In addition, Veeva has established an exclusive partnership with Pharma Advisors, headquartered in Madrid, Spain. Through these two new locations, Veeva will introduce its SaaS CRM solution to life sciences companies throughout Europe as well as provide local implementation and support services.

Veeva develops SaaS-based solutions for the global life sciences industry.

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