International Approvals: Primacoll, Lumenis One, Anodyne

Yael Waknine

June 28, 2005

June 28, 2005 — The European Commission has approved a resorbable bone graft substitute plus synthetic growth factor combination product for use in the permanent repair of bone defects caused by disease or trauma; China's State Food and Drug Administration has approved a multiapplication intense pulsed light and laser system for aesthetic applications; and Health Canada has approved a monochromatic infrared photo energy device for the temporary reduction of disturbances in skin sensation and increases in balance with reduction of fall risk due to diabetic and other peripheral neuropathies.

Resorbable Bone Void Filler with Synthetic Growth Factor (Primacoll) for Bone Repair in the European Union

The European Commission (EC) approved in June a resorbable bone graft substitute plus synthetic growth factor combination product (Primacoll, made by Millennium Biologix Corp.) for use in the permanent repair of bone defects caused by disease or trauma.

The biologically active bone and cartilage stimulating peptide is based on a specific sequence of human type 1 collagen that is found in natural bone. It is particularly effective in the initial stages of bone repair, and its synthetic nature eliminates the immunologic and disease transmission risks inherent in collagen extracted from animal sources.

The bone graft substitute is a synthetic resorbable biomaterial with an open cell reticulated structure similar to that of human cancellous bone. Its pore connectivity facilitates infiltration of the matrix by cells and nutrients, thereby promoting its postsurgical integration and gradual replacement with natural bone.

According to a company news release, the product is intended to provide a less expensive alternative to bone morphogenic protein products.

The bone graft component (Skelite) of the product was approved by the U.S. Food and Drug Administration, Health Canada, and the EC in May 2002, January 2003, and March 2004, respectively. The combination product is currently being evaluated for approval by Health Canada.

IPL and Laser System (Lumenis One) for Aesthetic Treatments in China

The State Food and Drug Administration of the People's Republic of China approved in June a multiapplication intense pulsed light (IPL) and laser system (Lumenis One, made by Lumenis Ltd.) for the treatment of a wide range of aesthetic conditions.

The system includes an IPL treatment head for use in skin photorejuvenation and the treatment of vascular and pigmented lesions, a Nd:YAG 1064-nm laser (Multi-Spot) for the treatment of deeper vascular lesions and leg veins, and a diode laser (LightSheer) for photoepilation.

User-oriented features include a touchscreen monitor and a "body mapping" interface.

Infrared-Emitting Device (Anodyne) Reduces Effects of Peripheral Neuropathy in Canada

On March 8, Health Canada approved a monochromatic infrared photo energy (MIRE) device (Anodyne Therapy System, made by Anodyne Therapy, LLC) for the temporary reduction of disturbances in skin sensation and increases in balance with reduction of fall risk (when used in conjunction with physical therapy) due to diabetic and other peripheral neuropathies.

The device delivers MIRE at pulses of 292 times per second through therapy arrays that each contain 60 superluminous diodes (890 nm, near infrared wavelength). Photo energy directed at the skin has been shown to increase microcirculation, possibly through the release of nitric oxide.

According to a company news release, MIRE therapy in conjunction with balance, gait, and strengthening physical therapy exercises can increase circulation to the feet, improve sensation and nerve function, reduce pain, help to heal chronic ulcers, and in some cases, prevent amputation.

Treatment can also improve balance and gaitand reduce the risk of falls by 96% in elderly patients with neuropathy. Recent studies also have shown MIRE to improve sensory perception, at least temporarily, in patients with diabetes.

Treatment sessions are conducted three times weekly for at least four weeks and can be safely used over pins, implants, screws, pacemakers, and defibrillators.

According to a company news release, the MIRE device is the first product to increase sensation and improve balance that has been diminished or lost due to peripheral neuropathy.

Reviewed by Gary D. Vogin, MD

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