A Medical Device Daily

Stereotaxis (St. Louis) reported that the first atrial fibrillation (AF) procedures performed with its partnered magnetic irrigated catheter were successfully completed recently. The magnetic irrigated catheter has CE-mark approval for the remote ablation of arrhythmias and is being released “in phases” to physicians in Europe, the company said.

“The first uses of our partnered irrigated catheter in Europe are a double achievement,” said CEO Bevil Hogg. “First, the cases were remarkable for their efficiency and efficacy, and we are extremely pleased with the results. Secondly, combined with our Stereotaxis Magnetic Navigation System and new NaviLine software, the irrigated catheter completes Stereotaxis’ total solution for atrial fibrillation, a solution that we believe will significantly advance the treatment of complex arrhythmias and potentially become standard of care for a growing number of cases.

Hogg added, “Near-term, we believe that widespread adoption of our partnered magnetic irrigated catheter in Europe will bring even greater simplicity and safety to AF procedures performed there, and we look forward to these clinical benefits becoming available to patients and clinicians in the U.S. after appropriate regulatory approval.”

Stereotaxis manufactures an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites.

The system uses computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting, the company said, in “improved navigation, shorter procedure time and reduced X-ray exposure.”

The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada, but use of cardiac ablation catheters for treatment of AF still is considered investigational in the U.S., the company said.

CE mark for Diamics’ Pap-Map System

Diamics (Novato, California) said that it has received the CE mark for its Pap-Map System for cervical cancer screening. Granted in the Netherlands, the registration will allow the system to be marketed in the European Union and other countries around the world that recognize CE-mark approval.

Comprised of the Pap-Map Cervical Cancer Collector, the Pap-Map Handle and the Transfer Station, the system allows the clinician to capture 360 degrees of cervical material and transfer the cells, with their spatial orientation intact, to a slide to support localization of identified lesions in both initial diagnosis and follow-up treatments.

“This CE-mark registration is a clear milestone for Diamics as it opens the door for commercialization of the system throughout the EU and other areas to help improve the detection of cervical cancer,” said Diamics CEO Peter Gombrich.

VP of Business Development Piush Vidyarthi said, “This approval clears the way for the Pap-Map system to establish itself as a platform for molecular-based cervical cancer screening.”

Cancer of the cervix is the second most commonly diagnosed cancer in women worldwide, with some 500,000 new cases diagnosed annually, 80% of which occur in developing countries. It is estimated that of the more than 2.5 billion females worldwide who are eligible for cervical cancer testing, only about 6%, or 160 million, are screened routinely.

Diamics is a developer of molecular-based cancer screening and diagnostic systems that will increase long-term cancer survival rates through early detection.

France sets reimbursement for Mobidisc

LDR (Austin, Texas), a privately held developer of spinal implants for both non-fusion and fusion applications, said it has been notified that the French government will reimburse surgeons using the company’s Mobidisc artificial lumbar disc.

The company said Mobidisc will join ProDisc-L and Charite as the only lumbar discs that the French government has approved for reimbursement.

President and CEO Christophe Lavigne said, “France continues to be a leader in spine innovation and artificial discs are positioned in a highly competitive environment. This approval validates our Mobi platform technology as well as the clinical performance of Mobidisc.”

The Mobidisc is designed to provide six degrees of freedom via a mobile-bearing technology, “thereby better replicating the natural kinematics of the spine,” according to LDR. Its design incorporates a low-profile keel and specialized delivery instrumentation that introduces the implant into the disc space via a safety guide.

Mobidisc was introduced in November 2003 and has been implanted in over 2,100 patients worldwide.

Jerome Allain, MD, of Henri Mondor University Hospital (Paris), said, “The Mobidisc is a true second-generation disc that has demonstrated strong clinical performance since its introduction over four years ago. It was created by a team of surgeons who leveraged their experience in developing the first generation of artificial discs to design the next evolution of lumbar disc replacement.”

LDR was founded in 2000 now is selling its products worldwide in more than 30 countries.

Italian distribution accord for CytoCore

CytoCore (Chicago), a developer of products for the early detection and treatment of reproductive-tract cancers, said it has entered into a three-year agreement with M.O.S.S. for distribution of the SoftPap Cervical Cell Collector into Italy.

M.O.S.S specializes in the distribution and maintenance of medical-surgical devices. Its agreement with CytoCore calls for minimum sales of 1 mm units the first year, 2 mm units the second, and 2.5 mm units in the third year.

CytoCore CEO Robert McCullough Jr. said, “We have received an initial order and expect to ship the first SoftPap product to M.O.S.S. by the end of November.”

M.O.S.S. was founded in 2000 as part of a larger group of medical distribution companies under the direction of Franco Papa. It is a part of TIMANT, a European-wide service network for medical equipment.