Navigation Links
Spinal Implant Developed by Sanford Clinic Neurosurgeon Receives FDA 510(k) Market Clearance as a Lumbar Intervertebral Body Fusion Device
Date:8/27/2009

SIOUX FALLS, S.D., Aug. 27 /PRNewswire/ -- Sanford Health, a comprehensive health care provider in the Upper Midwest, announced today a spinal implant developed by Sanford Clinic Neurosurgeon, Wilson Asfora, MD, Sanford Clinic Neurosurgery & Spine, has received United States Food and Drug Administration (FDA) 510(k) market clearance as a lumbar intervertebral body fusion device. On August 14, 2009, the FDA gave 510(k) clearance to the Asfora Bullet Cage, a product which is designed for use in posterior lumbar interbody fusion surgeries to treat degenerative disc disease. The Asfora Bullet Cage will be manufactured and sold by Medical Designs, LLC, a Sioux Falls company owned by Dr. Asfora.

"We congratulate Dr. Asfora on the FDA approval of his spinal implant," said Dave Link, Sanford Health Executive Vice President. "At Sanford Health, our goal is to foster an environment which supports the efforts of our physicians to develop innovative solutions for the global health care market."

Commenting on the FDA approval, Dr. Asfora said, "The 510(k) clearance of the Asfora Bullet Cage represents the culmination of a decade of clinical research. Clinical experience to date demonstrates up to a 98 percent rate of interbody fusion of one or two levels in hundreds of cases using simply locally harvested bone without unexpected complications and without the use of pedicle screws and Bone Morphogenic Protein."

Dr. Asfora currently serves as a Neurosurgeon at Sanford Clinic in Sioux Falls. He specializes in adult and pediatric neurosurgery, spine surgery, brain tumor surgery, cerebrovascular surgery, peripheral nerve surgery, radiosurgery and functional neurosurgery including Deep Brain Stimulation for Movement Disorders. Dr. Asfora is board certified with the American Board of Neurological Surgery and the Royal College of Physicians and Surgeons of Canada. Dr. Asfora has been with Sanford Health since 2007 and has worked as a Neurosurgeon since 1989.

Dr. Asfora has authored dozens of publications on issues related to neurosurgery. In addition, he has developed numerous medical devices in use at hospitals around the world including:

  • The Subdural Evacuating Port System ("SEPS"), a minimally invasive life saving device used to treat subdural hematomas and promote brain expansion without entering the subdural space. SEPS is now marketed globally by Medtronic, Inc.
  • The Dakota Knife, a surgical instrument for the transection of the Carpal Ligament in open, limited-open, or minimally invasive Carpal Tunnel surgery.
  • The Odontoid Curved Drill Guide, a surgical tool for anterior screw fixation of odontoid fractures. The device is particularly useful in Barrel Chested patients.

Through a research affiliation with Sanford Health, Dr. Asfora is currently leading a nation wide team of engineers, clinicians and regulatory experts in the development of new medical technologies for use in the fields of pain therapy, vascular surgery and pediatric diagnostics.

About Sanford Health

Based in Sioux Falls, SD, Sanford Health's comprehensive, integrated system includes nearly 440 providers in 128 clinic and satellite clinics. It also includes 23 hospitals, 12 nursing homes, 18 assisted living facilities and congregate living locations, 27 home health services and 19 pharmacies. With more than 10,000 employees, Sanford Health is the largest employer in the region. Its primary, 500-bed nonprofit tertiary care hospital in Sioux Falls, SD, serves an average of more than 50,000 inpatients annually. With more than 1.25 million outpatient visits each year, Sanford Health has served the 80,000 square mile, five-state region of South Dakota, Iowa, Minnesota, Nebraska and North Dakota for more than 110 years. Sanford Health is the largest healthcare system between Denver, CO and Mayo Clinic in Rochester, MN. Its divisions include Sanford USD Medical Center, Sanford Clinic, Sanford Health Network, Sanford Health Plan and Sanford Health Foundation. For more information, visit www.sanfordhealth.org.


'/>"/>
SOURCE Sanford Health
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Cialis Eases Erectile Dysfunction After Spinal Cord Injury
2. Summit on Spinal Muscular Atrophy
3. New Low-Back Pain Guidelines Should Encourage Patients to Utilize Spinal Manipulation
4. Pioneer Surgical Technology Hires New Spinal Franchise Manager
5. Video: Kyphon Supports World Osteoporosis Day on October 20, 2007 to Raise Awareness of Osteoporosis and Spinal Fracture Risk
6. Mayo Clinic clarifies diagnosis for serious blood vessel disease of brain and spinal cord
7. Spinal cord injury expert to be honored by research foundation
8. ArthroCare Releases New SpineWand(R) for Less Invasive Spinal Surgeries
9. Engineers developing new cements to heal spinal fractures
10. Polyanalgesic Consensus Panels New Treatment Guidelines Via Intraspinal Infusion for Severe Chronic Pain
11. Jefferson researchers find stem cells in degenerating spinal discs, potential for repair
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/28/2016)... ... 2016 , ... After a year and a half of planning the Multiple Pathways of ... Multiple Pathways of Recovery Conference was held May 2 -4, 2016 at the Mystic ... came together to explore the many pathways individuals use to get into and sustain their ...
(Date:5/27/2016)... ... May 27, 2016 , ... Two director-level employees of Horizon Blue Cross Blue ... Industry (TWIN) 2016 honorees. The award recognizes businesswomen who excel in their fields ... Director of the MLTSS (Managed Long-Term Services and Supports) Program at Horizon NJ Health ...
(Date:5/27/2016)... ... , ... This campaign aims to provide a path to improved education and ... and change. , As nearly 795,000 Americans suffering from a new or recurrent stoke ... with an estimated 129,000 of these people dying from stroke, it’s become our nation’s ...
(Date:5/27/2016)... ... 27, 2016 , ... Aimed at nurses and employees in ... courtesy of leaders in the nursing and health care industry. It also provides ... and associations—namely Jones & Bartlett Learning. , Jones & Bartlett Learning is adding ...
(Date:5/26/2016)... ... ... Despite last week’s media reports hinting at a June rate hike after the ... for an interest rate increase, according to Rajeev Dhawan of the Economic Forecasting Center ... Market Committee (FOMC) dot charts are of interest to the press for their noise ...
Breaking Medicine News(10 mins):
(Date:5/27/2016)... PUNE, India , May 27, 2016 ... in the instances of hypertension is driving ambulatory blood ... muscles lose their elasticity and their ability to respond ... blood pressure. This condition can lead to various cardiovascular ... and peripheral vascular disease. These diseases are growing in ...
(Date:5/26/2016)... , May 26, 2016 According ... "Medical Waste Management Market - U.S. Industry Analysis, Size, Share, ... management market in the U.S. was valued at US$ 5.89 ... CAGR of 3.4% from 2015 to 2023 to reach US$ ... analysis of current and emerging needle free drug delivery devices ...
(Date:5/25/2016)... May 25,2016 FDA 510(k) ... Cellvizio platform for urological and surgical applications ... inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy ... in the US with the 12 th ... Administration (FDA). This new FDA clearance covers Confocal ...
Breaking Medicine Technology: