A Medical Device Daily

Nexgen Spine (Whippany, New Jersey), a developer of spinal implants for the surgical treatment of degenerative disc disease, reported receiving CE-mark approval for its Physio-L lumbar artificial disc.

"This represents an important milestone in our plan to launch a full range of artificial disc prostheses based on our proprietary elastomeric disc technology," said Alastair Clemow, PhD, president/CEO of Nexgen. He added: "the fact that the Physio-L is the first of the next generation elastomeric lumbar discs to receive a CE mark makes this approval even more exciting."

The Physio-L is an elastomeric disc prosthesis designed for use in the lumbar spine for patients suffering from degenerative disc disease. The device's elastomeric technology enables the disc to closely mimic the mechanical properties of the natural disc and represents a significant advance over current designs of disc prostheses.

"The unique properties of the Physio-L help restore the natural shock absorption of the disc," said Casey Lee MD, chairman and founder of Nexgen. "This allows the surgeon to restore function to the patient's disc. The clinical data for the Physio-L are demonstrating outstanding improvements in both patient disability and pain, supporting the concept of using elastomeric polymers for total disc prostheses."

Abiomed to open Irish manufacturing unit

Abiomed (Danvers, Massachusetts) reported that it will open a new manufacturing facility in Athlone, Ireland, that it says will create 250 jobs over the next 18 months.

The plant will manufacture Abiomed's Impella 2.5 product for patients suffering acute heart failure, and it will be based at the site of the former Conor Medsystems (Menlo Park, California) factory, which closed with the loss of 165 jobs in May 2007.

The company will be moving portions of its manufacturing facility in Aachen, Germany, to Athlone. It said it expected the first manufacturing line in Athlone to be in production within 18 months.

Abiomed said its longer-term plans will be to designate Ireland as its global center of excellence for high-volume disposable product manufacturing.

Raysearch a consultant for Swedish hospital

RaySearch Laboratories (Stockholm, Sweden) has signed a consulting agreement with the Uppsala University Hospital (Uppsala, Sweden) covering the development of a new treatment planning system for proton radiation therapy delivered at the Svedberg Laboratory (Uppsala).

The system is planned for clinical use this year and will replace an outdated system for all patient treatments. Uppsala University Hospital treats more than 100 cancer patients annually with proton therapy.

"To capitalize on the advantages with proton therapy, which is more precise than conventional radiation therapy, a reliable and accurate dose calculation is of extra importance. This will be provided by this system from RaySearch," says Ulf Isacsson, who is responsible for radiation therapy at the Hospital Physics department of the hospital.

"We know that RaySearch has a fast development process in which we can be actively involved so we will get a modern user-friendly system that is fully integrated into our existing routines for radiation therapy," said Ulf Isacsson.

"The agreement has no direct financial impact on RaySearch, but it is of high strategic importance that our proton system will now be used clinically for the first time," said Johan L f, president of RaySearch.

RaySearch develops software solutions for improved radiation therapy of cancer.

Apligraf granted Swiss reimbursement

Regenerative medicine company Organogenesis (Canton, Massachusetts) reported that Apligraf, its living bi-layered cell therapy product used to treat non-healing wounds, gained Swiss reimbursement as of August 1.

"Swiss patients with non-healing wounds are the first in Europe to benefit from a fully reimbursed regenerative medicine therapy with Apligraf," said Geoff Mackay, CEO of Organogenesis.

"Patients suffering from diabetes or from circulatory insufficiencies often have long-lasting open wounds. Those may last over several years, and they significantly lower the quality of life," said Dr. Fiorenzo Angehrn, surgeon and head of the clinic Piano (Biel, Switzerland), who has treated patients with Apligraf for several years. "Many chronic wounds need to be treated with an active wound healing product, and therefore we welcome Apligraf as a true medical advancement."

Apligraf re-entered the Swiss market in October 2006. Treatment costs now will be fully reimbursed, according to appendix 1 of the Swiss reimbursement regulations for the treatment of chronic, poorly healing ulcers and for the treatment of soft tissue defects. Health insurers in Switzerland fully reimburse the product if treatment applies to the user-guidelines and to the certification process issued by the Swiss Association for Wound Care and the Swiss Association for Dermatology and Venerology.

Like human skin, Apligraf contains two layers of living cells: an outer epidermal layer of protective skin cells, and an inner dermal layer of cells that produce more than 40 substances such as cytokines and growth factors important for healing. When placed on a wound unresponsive to treatment, Apligraf is used to stimulate the body's own healing capabilities by releasing cytokines and growth factors into the neighboring tissue.

Russian hospital acquires a Cyberknife

Accuray (Sunnyvale, California) reported that the Burdenko Institute of Neurosurgery (Moscow) has purchased a CyberKnife robotic radiosurgery system.

When the system is installed, Burdenko Institute will become the second facility in Russia to offer these robotic radiosurgery treatments. The CyberKnife will enable the Burdenko Institute to expand its ability to treat tumors and other diseases of the brain and spine.

The Burdenko Institute will receive its CyberKnife System by the end of 2008 through local distributor Newstep.

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