Sulzer Spine-Tech Receives FDA Approval for BAK/C Cervical Interbody Fusion System

First Cervical Cage to Be Approved in the USA



Apr 23, 2001, 01:00 ET from Sulzer Medica Ltd.

    WINTERTHUR, Switzerland, April 23 /PRNewswire/ -- Sulzer Medica Ltd
 announced today that its subsidiary Sulzer Spine-Tech, based in Minneapolis,
 Minnesota, received approval from the US Food and Drug Administration (FDA) to
 begin commercializing the BAK/C(R) Cervical Interbody Fusion System.  The
 BAK/C device is the first cervical interbody fusion device to receive FDA
 approval.  Approximately 150 000 cervical fusions are performed in the USA
 alone with a value of USD 150 million.  The US market is assumed to grow at a
 rate of about 20% annually.
     The BAK/C device is a cylindrical titanium alloy implant for use in
 patients with painful degenerative disc disease at one disc level of the
 cervical spine.  The BAK/C device may be placed between the third and seventh
 cervical vertebrae.  The BAK/C device provides immediate stability and
 promotes fusion between vertebral bodies.
     "As we did with the introduction of the first lumbar interbody fusion
 device, Sulzer Spine-Tech is once again leading the industry with this
 first-to-market cervical interbody fusion device," said Rich Lunsford,
 President of Sulzer Spine-Tech.  Lunsford went on to say, "most surgeons
 prefer to use bone harvested from the patient (autograft) in cervical spinal
 fusion procedures.  Due to its unique design BAK/C collects local bone during
 implant insertion, resulting in autograft without the need for bone harvest
 from the patients' hip."
     Robert Hacker, MD, lead investigator on the clinical study for the BAK/C
 device was quoted as saying: "The results of this multi-center study showed
 significantly higher fusion rates at every follow-up interval for BAK/C
 patients when compared to ACDF (Anterior Cervical Diskectomy and Fusion)
 patients.  There were fewer complications reported in the BAK/C group -- 17%
 compared to 25% in the ACDF group.  The BAK/C device offers unique benefits,
 including avoidance of a painful bone graft harvest -- common with many
 current techniques -- and elimination of the need for a plate device that may
 interface with the esophagus and cause swallowing difficulties.  This
 treatment provides a great solution for surgical candidates suffering from
 painful, degenerative cervical disc disease."
     "Annually there are an estimated 150,000 cervical fusions in the US alone
 with a market value of USD 150 million," said Mike McCormick, Vice President
 of Sales and Marketing for Sulzer Spine-Tech.  "Surgeons have consistently
 told us they prefer autograft fusion, but their patients are plagued by the
 morbidity associated with hip harvest.  There is tremendous enthusiasm
 surrounding the BAK/C device since it can be used to obtain autograph fusion
 without taking bone from the patient's hip."
     Since its inception in 1991, Sulzer Spine-Tech has focused on designing
 and manufacturing comprehensive spine care solutions to improve customers'
 quality of life.
 
     Headquartered in Winterthur, Switzerland, Sulzer Medica develops,
 manufactures and markets implantable medical devices and biological products
 for cardiovascular and orthopedic markets worldwide.  The Company's product
 offering includes joint prostheses, spinal implants, dental implants, trauma
 surgery products, heart valves, peripheral stents, and vascular grafts
 (NYSE:   SM) (Swiss Stock Exchange: SMEN).
 
     THE SAFE HARBOR STATEMENTS UNDER THE U.S. PRIVATE SECURITIES LITIGATION
 REFORM ACT 1995
     This report contains forward-looking statements including, but not limited
 to, projections of future performance of materials and products, financial
 conditions, results of operations and cash flows, containing risks and
 uncertainties.  These statements are subject to change based on known risks
 detailed from time to time in the Company's Securities and Exchange Commission
 filings and other known and unknown risks and various other factors which
 could cause the actual results or performance to differ materially from the
 statements made herein.
 
     The press release is available on the internet:
     www.sulzermedica.com/media/mainpage.htm
 
 

SOURCE Sulzer Medica Ltd.
    WINTERTHUR, Switzerland, April 23 /PRNewswire/ -- Sulzer Medica Ltd
 announced today that its subsidiary Sulzer Spine-Tech, based in Minneapolis,
 Minnesota, received approval from the US Food and Drug Administration (FDA) to
 begin commercializing the BAK/C(R) Cervical Interbody Fusion System.  The
 BAK/C device is the first cervical interbody fusion device to receive FDA
 approval.  Approximately 150 000 cervical fusions are performed in the USA
 alone with a value of USD 150 million.  The US market is assumed to grow at a
 rate of about 20% annually.
     The BAK/C device is a cylindrical titanium alloy implant for use in
 patients with painful degenerative disc disease at one disc level of the
 cervical spine.  The BAK/C device may be placed between the third and seventh
 cervical vertebrae.  The BAK/C device provides immediate stability and
 promotes fusion between vertebral bodies.
     "As we did with the introduction of the first lumbar interbody fusion
 device, Sulzer Spine-Tech is once again leading the industry with this
 first-to-market cervical interbody fusion device," said Rich Lunsford,
 President of Sulzer Spine-Tech.  Lunsford went on to say, "most surgeons
 prefer to use bone harvested from the patient (autograft) in cervical spinal
 fusion procedures.  Due to its unique design BAK/C collects local bone during
 implant insertion, resulting in autograft without the need for bone harvest
 from the patients' hip."
     Robert Hacker, MD, lead investigator on the clinical study for the BAK/C
 device was quoted as saying: "The results of this multi-center study showed
 significantly higher fusion rates at every follow-up interval for BAK/C
 patients when compared to ACDF (Anterior Cervical Diskectomy and Fusion)
 patients.  There were fewer complications reported in the BAK/C group -- 17%
 compared to 25% in the ACDF group.  The BAK/C device offers unique benefits,
 including avoidance of a painful bone graft harvest -- common with many
 current techniques -- and elimination of the need for a plate device that may
 interface with the esophagus and cause swallowing difficulties.  This
 treatment provides a great solution for surgical candidates suffering from
 painful, degenerative cervical disc disease."
     "Annually there are an estimated 150,000 cervical fusions in the US alone
 with a market value of USD 150 million," said Mike McCormick, Vice President
 of Sales and Marketing for Sulzer Spine-Tech.  "Surgeons have consistently
 told us they prefer autograft fusion, but their patients are plagued by the
 morbidity associated with hip harvest.  There is tremendous enthusiasm
 surrounding the BAK/C device since it can be used to obtain autograph fusion
 without taking bone from the patient's hip."
     Since its inception in 1991, Sulzer Spine-Tech has focused on designing
 and manufacturing comprehensive spine care solutions to improve customers'
 quality of life.
 
     Headquartered in Winterthur, Switzerland, Sulzer Medica develops,
 manufactures and markets implantable medical devices and biological products
 for cardiovascular and orthopedic markets worldwide.  The Company's product
 offering includes joint prostheses, spinal implants, dental implants, trauma
 surgery products, heart valves, peripheral stents, and vascular grafts
 (NYSE:   SM) (Swiss Stock Exchange: SMEN).
 
     THE SAFE HARBOR STATEMENTS UNDER THE U.S. PRIVATE SECURITIES LITIGATION
 REFORM ACT 1995
     This report contains forward-looking statements including, but not limited
 to, projections of future performance of materials and products, financial
 conditions, results of operations and cash flows, containing risks and
 uncertainties.  These statements are subject to change based on known risks
 detailed from time to time in the Company's Securities and Exchange Commission
 filings and other known and unknown risks and various other factors which
 could cause the actual results or performance to differ materially from the
 statements made herein.
 
     The press release is available on the internet:
     www.sulzermedica.com/media/mainpage.htm
 
 SOURCE  Sulzer Medica Ltd.