A Medical Device Daily

AxioMed Spine (Garfield Heights, Ohio) reported the receipt of CE-mark approval for its Freedom Lumbar Disc, an elastomeric total spinal disc replacement device.

The CE-mark approval was received from the company's notified body after review of its multi-center European clinical study and portfolio of biocompatibility and biomechanical testing.

This data also supported AxioMed's Investigational Device Exemption approval by the FDA.

President/CEO Patrick McBrayer said, "The Freedom Lumbar Disc is the only elastomeric lumbar total disc replacement device to receive CE-mark approval based on a rigorous multi-center clinical study conducted in the European Union. We are . . . pleased to be able to provide surgeons in Europe with the Freedom technology that has been shown to provide patients pain relief, reduced disability and improved lifestyle, based on monitored outcomes and feedback."

Neal Defibaugh, the company's vice president of clinical and regulatory affairs, said, "Our European clinical study results, coupled with the extensive portfolio of biocompatibility and biomechanical testing, provided substantial information for our notified body to assess the Freedom Lumbar Disc."

The Freedom Lumbar Disc is a viscoelastic one-piece, next-generation total disc replacement featuring a polymer core, designed with the goal of restoring function of the spine and reducing pain and disability.

1st cases for LipiScan catheter

InfraReDx (Burlington, Massachusetts) reported the first use in patients of a novel coronary catheter that uses both light and sound to image coronary plaques. Working on a team led by Patrick Serruys, MD, Martin van der Ent, MD, performed the procedures on patients undergoing coronary angiography at the Thoraxcenter (Rotterdam, the Netherlands).

The LipiScan Coronary Imaging System is a catheter-based device that uses laser light to detect how much fat and other substances are contained in a plaque.

The company said the combination catheter provides the benefits of both IVUS and NIRS imaging in a single study of the artery. IVUS is commonly used to quantify the degree of narrowing produced by a plaque, the size of the artery and the adequacy of stent expansion.

NIRS is a novel technique recently cleared by the FDA for the identification of lipid core plaques, the structures suspected to cause most heart attacks and complicate stenting procedures.

Serruys said, "The composition of atherosclerotic plaques is important in assessing the likelihood that they will cause cardiovascular events. This novel device provides composition on top of anatomy and will play a pivotal role in interventional cardiology, first in clinical trials and further on in treatment planning in individual patients."

The Biomedical Engineering Department of the Thoraxcenter, led by Ton van der Steen, MD, provided expertise essential to the addition of IVUS to the NIRS system, according to the company.

"In order to determine both composition and structure of an atherosclerotic plaque, a combination catheter is necessary. I am truly excited that InfraReDx teamed up with the Thoraxcenter in this development, both from a technical and a clinical perspective," said van der Steen.

James Muller, MD, a cardiologist and co-founder/CEO of InfraReDx, said, "The InfraReDx team is proud to have developed the first combined optical and acoustic catheter for use in the coronary arteries of patients. The addition of IVUS to our FDA cleared LipiScan catheter provides a novel tool that we believe will assist physicians with the complex decisions they face in the management of patients with coronary artery disease."

French court finds infringement

Instrumentation Laboratory (IL; Bedford, Massachusetts) reported that the Paris First Level Civil Court has determined that Diagnostica Stago (Paris) infringed the French counterparts of two European patents licensed exclusively to IL, and committed acts of unfair competition due to denigrating advertisements.

The court ruled that: 1) Diagnostica Stago must cease manufacturing and selling its infringing products, STA-Staclot APC-R kits and Stagen Kit FVM Mutation, and must cease denigrating advertisements concerning IL's products; 2) Diagnostica Stago's inventory of STA-Staclot APC-R kits and Stagen Kit FVM Mutation may be confiscated for potential future destruction; and 3) Diagnostica Stago must pay IL the sum of €2 million (about $2.6 million) as an advance on damages for the infringement and unfair competition, plus attorneys' fees.

The court's decision may be appealed.

IL is the exclusive licensee of two patents, EP 0 608 235 and EP 0 690 991, covering inventions from researcher Dr. Bjorn Dahlback, relating to the detection of thrombophilia, a coagulation disorder, in human blood.

The first patent relates to a method for diagnosing a human blood coagulation disorder called resistance to APC (activated protein C resistance), while the second patent additionally relates to a method for determining the presence of gene mutations of Factor V, which is one of the causes of thrombophilia.