A Medical Device Daily Staff Report

Dfine (San Jose, California) has received CE mark approval for the STAR tumor ablation system for treatment of painful metastatic spinal tumors. The company will launch the STAR system in Europe at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress, held in Barcelona, Spain. The STAR System received FDA clearance in the U.S. in August 2010 and has demonstrated strong clinical outcomes at centers across the country.

"We are very excited to bring this new treatment modality to Europe so that the hundreds of thousands of patients suffering from painful spinal tumors can receive the rapid pain relief that patients here in the U.S. have experienced. This represents a significant milestone for the company," said Greg Barrett, CEO of Dfine.

Cancer is a major public health problem throughout the world, with more than 3.4 million new diagnoses each year in Europe alone. When cancer is not found early, it can spread or metastasize to other parts of the body. A spinal tumor is a growth of cells (mass) in or around the vertebra near the spinal cord. It is estimated that 30%-40% of cancer patients will likely develop metastatic spinal tumors.

Patients suffering from painful spinal tumors have limited options. Many are in excruciating pain and unable to perform activities of daily living. Targeted RF ablation (t-RFA) with the STAR Tumor Ablation System was developed specifically for metastatic vertebral body tumors. The physician can target precisely where the device's energy is delivered to heat and destroy the tumor, providing rapid and lasting pain relief in a single treatment.

Dfine says it is dedicated to relieving pain and improving the quality of life for patients suffering from diseases of the spine through innovative, minimally invasive, targeted therapies.

SpineJack stands up better than kyphoplasty

In a comparative study head-to-head with balloon kyphoplasty, the SpineJack device developed by Vexim (Toulouse, France) was found to demonstrate a significant advantage in restoring and maintaining height afterv treatment for unstable osteoporotic vertebral compression fractures.

Published in the current issue of Clinical Biomechanics, the study was conducted by the Traumatology group at Philipp's University (Marburg, Germany), which evalutaed 36 fractured vertebral bodies.

"The vertebral height restoration was over 93% for the groups treated with SpineJack even after recompression", according to principal investigator Antonio Krüger, MD, an orthopedic trauma surgeon.

Twenty-seven vertebrae were treated with the SpineJack with different cement volumes while nine vertebrae were treated with balloon kyphoplasty.

Vertebral heights were measured pre- and post-fracture, as well as after treatment and loading.

While Krüger reported height restoration was significantly better for the SpineJack group, he noted height maintenance was dependent on the cement volume used and cautioned that the statistical significance could not be demonstrated.

SpineJack is a 5 mm, expandable titanium device measuring 25 mm in length that is implanted in a minimally invasive procedure, typically through two skin incisions.

Once inserted and expanded to the required height, bone cement is injected into the vertebra in order to fixate the restored structure.

Syneron cleared for VelaShape III Platform

Syneron Medical (Irvine, California) reported FDA clearance and CE mark approval for VelaShape III, the company's new non-invasive body shaping platform. This new platform is effective for temporary reduction in circumference of the abdomen and is also used in a wide range of other body shaping applications such as cellulite treatments.

"In a VelaShape III clinical study of forty-two patients an average abdominal circumference reduction of 2.6 cm was recorded post 10 weeks following a single treatment," said Ruthie Amir, MD, global VP of clinical affairs. "Within the same study, we uncovered that 100 percent of the patients responded to the single treatment protocol with an abdominal circumference reduction of at a least 1.5 cm, with results seen as early as two weeks."

Based on the energy combination technology of elos and with the extensive scientific and clinical experience accumulated from all the Vela brands, the new VelaShape III system comes equipped with a multitude of new features designed to significantly reduce the number of treatments while reducing the percentage of non-responders. Some of these new features include increased radio-frequency power of up to 150W, sophisticated real time feedback mechanisms for consistent RF delivery independent of tissue variations and a built-in, real time tissue surface temperature sensor. The system also offers a complete range of new tip configurations for various body locations. All these advanced features have been packaged into a sleek, state-of-the-art design with a highly optimized and user-friendly interface.

The company claims the VelaShape III is proven to be safe and effective in significant waist circumference reduction – a common problem area that can be resistant to exercise and dieting which add to its other well established indications including treatment of cellulite and thigh circumferential reduction.

Syneron Medical is an aesthetic device company.

No Comments