Nucleotome – Clarus Medical LLC

Quantify your results.

For minimally invasive automated percutaneous cervical and lumbar discectomy.

NUCLEOTOME SETS THE STANDARD FOR SAFETY AND EFFICACY IN PERCUTANEOUS DISCECTOMY.

Nucleotome uses an automated shaver and continuous irrigation to remove disc nucleus. Surgical intruments are available for use through the working cannula, giving physicians the capability to reach the desired end point. The Nucleotome has a blunt distal tip and produces no heat, which translates to safety and patient comfort. Nuclear material is aspirated and collected for post-op examination.

The Nucleotome percutaneous discectomy kits are indicated for patients with contained herniated discs following failed conservative treatment. Numerous studies have proven the efficacy to be 75% and higher in properly selected patients.

There are minimal risks to patients. Complication rates are consistently less than 1%. Most percutaneous procedures are performed under local anesthesia. Patients can be discharged the same day and return to an active lifestyle quickly.

Nucleotome percutaneous kits allow physicians to safely extract enough nucleus to sufficiently decompress the disc. This is achieved through a small puncture without removing bone or disturbing the epidural space. With the Nucleotome, you can visualize and quantify the tissue removed.

OPERATION OF NUCLEOTOME PROBE

The system’s unique vacuum design aspirates nucleus tissue into the probe. An inner cutter blade within the probe removes unwanted nucleus. Then flushes it to a tissue filter using continuous irrigation.

DISTAL TIP

The Nucleotome’s blunt probe tip and side operating cutter contribute to an unparalleled safety record.

NUCLEOTOME PROCEDURAL RESULTS

The Nucleotome Automated Discectomy System allows physicians to visualize the results of the disc decompression.

Clarus Forceps

Added versatility of forceps during percutaneous discectomy helps loosen material in tougher discs.

Nucleotome Brochure

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CLINICAL BACKGROUND

Minimally invasive spine surgery has been shown to be more successful than conventional surgery when applied to appropriately selected patients. ^2,3

Success rates for the Nucleotome procedure have consistently produced results greater than 75% and many over 80%. ^1,2,4,7

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. ^{1,2,3,4,5,6,7,8}

Minimally invasive spine surgery shares the advantages of low morbidity, reduced postoperative pain and short recovery time common to all successful minimally invasive surgical techniques. ^1,2,3,6,7,8

The design of the Nucleotome’s tip adds to it’s safety because it will not cut annulus and the blunt end minimizes risk of penetrating opposite annulus3. Well over 140,000 cases have been performed worldwide without a reported mortality associated with the procedure. ⁷

CLINICAL REFERENCES

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, Orthopaedics, 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, Volume 10, Number 3, August 2000.

8. Bonaldi: Automated Percutaneous Lumbar Discectomy: Technique, Indications and Clinical Follow-up in Over 1,000 Patients, Neuroradiology (2003) 45: 735-743.