A Medical Device Daily

InfraScan (Philadelphia), a device firm specializing in brain injury diagnostic products, reported receiving the CE mark for the Infrascanner handheld brain hematoma detector. The company said it plans to launch international sales this fall.

The Infrascanner is a small, completely portable device, which can detect the presence and location of a brain hematoma based on differential NIR light absorption of a hematoma and normal brain tissue.

InfraScan will present the results of a pivotal, 400-patient, multi-center study to the FDA later this year to support its 510(k) application and a subsequent U.S. launch of the device.

It said a pilot study with an earlier Infrascanner prototype involving more than 300 patients demonstrated high sensitivity for detecting bleeding in the brain and for rapidly detecting the onset of delayed hematomas.

"Receiving our CE mark represents significant progress toward InfraScan's strategic goal of providing our potentially life-saving technology to patients in some of the world's top established and emerging markets," said President/CEO Baruch Ben Dor, PhD.

He noted that the company had passed a British Standards Institute audit and received ISO 13485:2003 quality certification earlier this year. "This facilitated our obtaining the CE mark for the Infrascanner and allowed us to sign our first distributors in the UK, Spain, Israel, India and Africa," Dor said

Infrascan says the Infrascanner is "the first hand-held device of its kind designed to assist first responders and emergency room personnel in identifying life-threatening brain hematomas, allowing expedient assessment of patients and potentially facilitating crucial treatment."

It added, "Intracranial hematomas resulting from a traumatic brain injury are life-threatening and patient outcomes can improve significantly if treated within an hour after an injury – known as the 'golden hour.'"

The company noted that, "while most hospitals have a computer-aided tomography scanner, which is viewed as the state-of-the-art technology for diagnosing a brain hematoma, many facilities lack the neurosurgical capabilities to treat the condition."

It said the early identification of a brain hematoma "can play a significant role in facilitating transportation of critically injured patients to facilities, which can both verify Infrascanner's early diagnosis and offer surgical intervention."

An estimated 1.5 million individuals seek medical treatment for head trauma in the U.S. each year, and a total of 10 million individuals seek head trauma treatment annually worldwide, the company said.

In addition to the Infrascanner's first application for detecting brain hematomas, the company will pursue future applications for the product, including the monitoring of stroke victims using the same NIR technology.

InfraScan has received early-stage funding from the Office of Naval Research, BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania, Ben Franklin Technology Partners of Southeastern Pennsylvania, and from the Philadelphia Industrial Development Corp.

Norwegian hospital installs new Leksell Knife

Haukeland University Hospital (Bergen, Norway) has installed the Leksell Gamma Knife Perfexion from Elekta (Stockholm, Sweden), which the company describes as "the latest technology for treatment of brain disorders."

This new-generation Leksell Gamma Knife is fully automated and has the ability to treat patients with multiple brain metastases in much shorter times compared to other technologies, the company said.

Gamma Knife surgery is used to manage numerous neurosurgical conditions, including brain tumors such as metastatic cancer, as well as vascular malformations and certain functional disorders. Elekta said this method "provides pinpoint accuracy, is highly efficient and produces outstanding results."

The company added, "Patients benefit from fast, painless treatment, often conducted in an outpatient surgical setting without the need for general anesthesia or even convalescence."

To date, more than 500,000 patients worldwide have undergone Gamma Knife surgery.

"Leksell Gamma Knife Perfexion technology represents a major advance in brain radiosurgery," said Olof Sandén, executive vice president, Elekta Europe, Africa & Latin America. "It also offers enormous opportunities to treat lesions all over the brain in a single treatment, while also ensuring excellent patient comfort."

Leksell Gamma Knife Perfexion was introduced two years ago and the company has about 30 systems around the world.

ISO certification for Cardiac Dimensions

Cardiac Dimensions (Kirkland, Washington) said it has received ISO 13485:2003 certification from KEMA Quality BV, a European Union Notified Body from the Netherlands. The company noted that ISO certification is a key requirement in obtaining the CE mark.

Paul Cornelison, vice president of regulatory affairs & quality assurance at Cardiac Dimensions, said, "This certification validates the company's efforts to establish, document and maintain an effective quality management system. The entire company has been committed to achieving and maintaining this status."

President/CEO Rick Stewart said, "The ISO certification ... represents a validation of our high standards in terms of product design along with our manufacturing and distribution processes. We are also working toward gaining the CE mark for our Carillon system; this ISO certification provides a foundation to meet the specific quality requirements for the countries that accept CE marking."

The Carillon Mitral Contour System combines an implantable device and delivery system. The implant consists of a shaping ribbon between distal and proximal anchors. It is delivered percutaneously via jugular access under fluoroscopic guidance. The implant is designed to be positioned, adjusted and gently anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve, thereby reducing mitral regurgitation.

Pre-clinical and early clinical data have suggested both a reduction in mitral regurgitation and improvements along other key parameters, including New York Heart Association class, 6-minute walk times and quality of life.

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