CLINICAL BACKGROUND

Minimally invasive spine surgery has been shown to be more successful than conventional surgery when applied to appropriately selected patients.

Success rates for the Nucleotome procedure have consistently produced results greater than 75% and many over 80%.

Complication rates for percutaneous spine procedures have consistently been reported at less than 1%, a considerable reduction from the normal 3% to 4% reported for open spine surgery.

Minimally invasive spine surgery shares the advantages of low morbidity, reduces postoperative pain and short recovery time common to all successful minimally invasive surgical techniques.

The design of the Nucleotome's tip adds to its safety because it will not cut annulus and the blunt end minimizes risk of penetrating opposite annulus. Well over 125,000 cases have been performed worldwide without a reported mortality associated with the procedure.

Bendable Nucleotome™

for Open Lumbar Discectomy

NUCLEOTOME® BENEFITS

Provides a safe and effective treatment at all lumbar levels. Has continuous irrigation to remove tissue and toxins. Minimizes risk of epidural scarring. Allows the physician to collect and examine the extracted tissue. Performed under local anesthesia. Provides a more economic mode of treatment.

The Nucleotome System:

Nucleotome Console - with proven reliability, it operates all Nucleotome products. Sterile Disposable Accessory Set - includes all required components - guide needle, working cannula, dilator, trephine and Nucleotome probe - all in one set.

Nucleotome Probes:

Rounded tip reduces risk of penetration of the anterior annulus. Enclosed "guillotine:" cutting action ensures maximum safety. Resects and aspirates nucleus in one step. Functional at all lumbar levels. Does not cut annulus or endplates. Available in diameters and lengths to meet the requirements of both physician and patient.

CLINICAL REFRENCES

(1) Davis, et al.: Automated Percutaneous Discectomy, Spine, 1991.

(2)Sweicicki: Results of Automated Percutaneous Lumbar Discectomy Compared to Laminotomy and Chemo-Nucleolysis, Paper 22, Presented at the International Percutaneous Meeting, Spain, 1989

(3)Onik, Mooney, Maroon, et al: Automated Percutaneous Discectomy: a Prospective Multi-Institutional Study, Neurosurgery, 1990.

(4)Maroon: A Retrospective Study of 1054 APLD Cases: A Twenty Month Clinical Follow-up at Thirty Five US Centers, Paper Thirty Seven, International Percutaneous Meeting, Spain, 1989.

(5)Gill, Blumenthal: Clinic Experience with Automated Percutaneous Discectomy: The Nucleotome System, Orthopedics, 1991.

(6)Onik, Kambin, Chang: Controversy, Minimally Invasive Disc Surgery, Nucleotome Versus Fragmentectomy, Spine, 1997.

(7) Onik: Percutaneous Diskectomy in the Treatment of Herniated Lumbar Disks, Spine Interventions, V.10, N.3, Aug 2003.

(8) Bonaldi: Automated Percutaneous Lumbar Discectomy: Technique, Indications and Clinical Follow-up in Over 1000 Patients, Neuroradiology, 2003, 45:735-743.