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Friday, October 23, 2009

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Synthetic Bone Available for Use in Europe

October, 12, 2000 --Sulzer Spine-Tech, a subsidiary of Sulzer Medica, and Orquest, Inc., announced at the EuroSpine 2000 meeting in Antwerp, Belgium, the market launch of a new biological product that acts as a template for bone formation. Healos(R) Bone Graft Substitute, bioengineered from the same collagen and mineral that are found naturally in bone, is designed to eliminate a painful, costly and time consuming surgical procedure.

Healos has received CE Mark clearance in Europe for use as a replacement for bone material which is normally harvested from the patient's hip. This bone material, (autograft) is used in spinal surgery to support the fusion of two vertebrae.

Healos - A Synthetic Substitute for Autograft

Autograft represents the clinical gold standard in spinal fusion operations and other bone grafting applications. Healos is the first synthetic product that has performed as well as autograft in a controlled spinal fusion clinical study.

Each year more than 600,000 spinal fusion procedures are performed worldwide to treat patients suffering from debilitating back pain or injury. A synthetic substitute for autograft in spinal fusion is a major unmet medical need because the autograft harvesting procedure increases surgery time, can cause chronic hip pain and deformity, a longer hospital stay and post-operative disability.

In new two-year data to be presented at a seminar preceding EuroSpine 2000, patients treated with Healos continue to demonstrate excellent clinical results and to experience relief from their back pain. In addition, over 200 patients have been treated with Healos since the beginning of 2000 in 30 hospitals across Europe.

Healos Availability

In the U.S., Healos is currently under clinical investigation in combination with Sulzer Spine-Tech's BAK(TM) Interbody Fusion system of cage implants and has been implanted in over 100 patients. Healos (R) Bone Graft Substitute is available for sale in Europe through Sulzer Medica.

"We are excited to introduce Healos to spine surgeons throughout the European Community," said Rich Lunsford, General Manager of Sulzer Spine-Tech, a subsidiary of Sulzer Medica. "Healos represents a true advance in less invasive treatments for spine care."

Gregory D. Casciaro, President and CEO of Orquest, Inc., the developer of Healos, said "Healos is the first real off-the-shelf alternative to the very painful procedure of cutting away the patient's own bone for use in spinal fusion surgery. We believe Healos will have a huge impact on the billion dollar bone grafting market because it improves patient well being, reduces provider costs, and is easy to use."

Sulzer Medica

Sulzer Medica, the parent company of Sulzer Spine-Tech, is headquartered in Winterthur, Switzerland. It develops, manufactures and markets implantable medical devices and biomaterials for the cardiovascular and orthopaedic markets worldwide. (Swiss Stock Exchange:SMEN) (NYSE:SM). Sulzer Spine-Tech, based in Minneapolis, Minn., is a worldwide leader in minimally invasive spine surgery technology. As the pioneer in interbody fusion cages, Sulzer Spine-Tech first introduced the BAK system of implants to the US marketplace in September 1996. Over 40,000 procedures have been performed using BAK interbody fusion cages.

Orquest

Orquest is a privately held medical technology company dedicated to setting new biological standards of care in orthopaedics. With two platform technologies and several novel products in the clinic, Orquest is the clear leader in orthobiologics. The Company's products encompass the growth market segments in orthopaedics: spine surgery, fracture management, and cartilage repair. Healos Bone Graft Substitute joins HealosMP52, a next generation bone grafting matrix, and Ossigel(R) -- an injectable product for fracture healing -- in Orquest's expanding line of materials for bone and cartilage regeneration.