A Medical Device Daily

Hansen Medical (Mountain View, California), a developer of flexible robotics and robotic technology for accurate 3-D control of catheter movement, reported that a team of physicians led by Professor Nick Cheshire at St. Mary's Hospital (London), part of the Imperial College Healthcare NHS Trust in London, used its Sensei robotic catheter system and Artisan control catheter to aid deployment of stent grafts used to treat an abdominal aortic aneurysm in a 78-year-old patient.

The company said it believes this is the world's first procedure in which any robotic medical technology has been used to repair an aortic aneurysm through a patient's vascular system.

"We have always believed vascular surgery would provide a very natural application for our Sensei and Artisan robotic technology, and the recent advancement at St. Mary's Hospital demonstrates what is already within reach for our technology in this field," said Fred Moll, MD, co-founder and CEO of Hansen. "Just as important, the recent experience of clinicians at St. Mary's Hospital clearly demonstrates what physicians can accomplish when they use Hansen Medical's advanced technology to provide more precise movement and control during different types of surgery."

"The time taken to correctly position a stent graft during the treatment of an aneurysm is highly variable and depends on the complexity of the vascular anatomy," explained Professor Nick Cheshire. "By providing increased catheter stability and accurate navigation, the Sensei system has the potential to greatly simplify the procedure and make it more predictable. In this case, it only took a few minutes to drive the Artisan catheter to the location where the stent was to be deployed."

An abdominal aortic aneurysm results from weakening and swelling of the artery's walls, often as people age, and is frequently fatal if it ruptures. When positioned across the weakened section, stent grafts act as scaffolding that can help prevent the aneurysm from bursting. This surgery was performed through accessing the patient's vascular system at the groin and using Hansen Medical's Sensei system to accurately navigate the Artisan catheter up into the weakened section of the aorta, where the stent grafts were placed.

Stereotaxis reports catheter use reintroduced

Stereotaxis (St. Louis) reported that the first atrial fibrillation (AF) procedures using its re-introduced partnered magnetic irrigated catheter were successfully performed in Europe last week.

The catheter received CE-mark approval in the last week of August following its resubmission to European regulators by the company's partner in July 2008, and these first cases are part of the standard pre-release evaluation.

Also in July, the company's partner submitted a PMA supplement to the FDA for use of the magnetic catheter in the U.S. with the expectation that U.S. approval would be obtained subsequent to the CE mark.

Carlo Pappone MD, PhD, performed the first procedures last week at San Raffaele University Hospital (Milan, Italy).

Pappone said he was "delighted with the results of my first procedures performed successfully with the newly available Biosense magnetic irrigated catheter. I am extremely happy with its performance, and believe that Biosense did an excellent job. Contact stability, lesion quality and overall mechanical performance are excellent, and I believe safety is likely to be exemplary."

Bevil Hogg, CEO of Stereotaxis, said, "We are very pleased with the successful initial experience of our partnered magnetic catheter following its recent re-introduction in Europe. Most importantly, we anticipate that the commercial re-introduction of this catheter, which is used primarily for complex procedures in the left atrium of the heart, will mark a point of inflection in the utilization of our installed base of Niobe systems, resulting in a substantial increase in procedure volume over time and a concomitant acceleration of system sales."

StemCor's MarrowMiner system wins CE mark

StemCor Systems (Menlo Park, California), a company developing regenerative medicine systems, reported receiving the CE mark for its MarrowMiner system, a minimally invasive device used to harvest adult stem cells from the ilium (pelvis). The company calls the system a "next-generation technology" for use in bone marrow transplants, for accelerating bone healing in spinal fusions and other orthopedic procedures, and an expanding array of clinical applications utilizing bone marrow-derived cells.

"We are excited that this regulatory authorization gives us the ability to commercialize StemCor Systems' technology in the European Union," said Vartan Ghazarossian, PhD, president/CEO of StemCor. "The use of adult-derived stems cells is expanding rapidly, especially in spine fusion and other orthopedic procedures. We are pleased to be able to offer this novel device to physicians outside of the U.S., whereby bone marrow can be harvested in a more facile and relatively atraumatic way compared to traditional methods."

Pacsgear opens European office in Munich

Pacsgear (Pleasanton, California), a provider of document and multimedia connectivity solutions for hospitals and healthcare facilities, reported the establishment of its European office in Munich, Germany. Pacsgear's European office will provide sales and logistics functions in support of the company's products, which connect medical image management and electronic health record systems.

"We recognize the importance of building a direct presence in our core markets," said Brian Cavanaugh, president of Pacsgear. "The European office will let us directly serve our OEM partners, customers and distributors.

The company's products have CE marking and are available in six European languages.

Pacsgear provides document and multimedia connectivity solutions for medical image management and electronic health record systems.

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