Navigation Links
Pioneer(R) Surgical Technology's NuBac(R) Nucleus Replacement Device Wins FDA Approval for IDE Pivotal Study

First Company to Reach Pivotal Study for Spine Nucleus Replacement

MARQUETTE, Mich., Oct. 30 /PRNewswire/ -- Pioneer Surgical Technology, Inc. announced today, the U.S. Food and Drug Administration (FDA) granted approval to proceed to IDE Pivotal Study of the NuBac(R) Nucleus Replacement Device for the spine.

Pioneer's CEO and Chairman of the Board, Matthew N. Songer, MD, MBA says, "This is a huge milestone and accomplishment for Pioneer to be the first to receive FDA approval to start the IDE pivotal study for nucleus replacement. Many other companies, pursuing nucleus replacement technology, have spent more time and money than Pioneer and have not achieved this significant goal." Songer added, "This record speed to obtain FDA approval to proceed demonstrates our dedication to focused innovation and ability to bring new products to market faster than many of our competitors."

The NuBac implant system is the only Nucleus Replacement device that utilizes an articulating inner ball and socket design that seeks to achieve load sharing and uniform stress distribution under various physiological loading conditions while minimizing extrusion risk. The NuBac implant is made of PEEK-OPTIMA(R) material which offers well established biocompatibility, biodurability, excellent wear resistance, and radiolucency.

Pioneer's Vice President for Advanced Spine, Chip Bao, PhD states, "There are some inherent challenges in the development of nucleus replacement devices. Pioneer's unique design features of the NuBac implant have led to a series of successful pre-clinical studies and encouraging results from both the initial U.S. IDE feasibility study and post-market surveillance outside the U.S. under the CE mark."

Spinal Disc Arthroplasty surgery includes Total Disc Replacement (TDR) and Nucleus Replacement procedures. Both techniques seek to relieve discogenic back pain caused by degenerative disc disease, restore stability and flexibility to the affected spine segment. Nucleus Replacement procedures are commonly less invasive, more tissue preserving, and less bridge-burning than TDR surgery. Reducing the risk of having to perform revision surgery in the future would benefit a much broader population than TDR including patients, surgeons, hospitals, and payers.

Pioneer's signature, articulating P3(TM) Technology- Pioneer PEEK-on-PEEK- is the heart of the NuBac design. The company's other P3 motion preservation products are the NuNec(TM) artificial cervical disc and the BacJac(TM) interspinous decompression system. All three products are currently available in Europe under CE mark and provide patients and surgeons with the most technologically advanced designs in the industry.

Earlier this year, Pioneer announced significant findings on the effect of accelerated aging on the wear of PEEK (Poly-ether-ether-ketone). The study, conducted in collaboration with RUSH University in Chicago, determined that wear properties of PEEK-on-PEEK are not susceptible to the effects of accelerated aging. The study bolsters support for the long term durability of the company's P3 designs.

About Pioneer Surgical Technology

Pioneer Surgical Technology, Inc., headquartered in Marquette, Michigan, is a dynamic medical device firm with a full line of cutting-edge motion preservation devices, either available commercially in Europe or under clinical evaluation in the U.S. Pioneer's signature articulating P3(TM) Technology - Pioneer PEEK-on-PEEK, in its NuBac(TM) disc arthroplasty system, BacJac(TM) interspinous decompression system, and NuNec(TM) artificial cervical disc, is the most technologically advanced in the industry. Currently, Pioneer offers a diverse portfolio of next generation spinal fusion devices. Pioneer's focus on innovation has resulted in over 100 U.S. and Foreign patents with numerous patents pending. The company established a Biologics Division following two acquisitions in 2007. Pioneer Orthobiologics is developing a rich pipeline of products indicated for a variety of spinal and orthopaedic applications. Pioneer focuses on developing products which are easier and faster for the surgeon, cost effective for the health care system, and provide better patient outcomes.

SOURCE Pioneer Surgical Technology, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Pioneer(R) Surgical Technology Announces the Market Release of its Cross-Fuse(TM) Lateral Vertebral Body Replacement (VBR) System
2. Pioneer(R) Surgical Technology Introduces the BacJac(TM) Interspinous Decompression System to the European Spine Market
3. Pioneer(R) Surgical Technology, Inc. Continues to Prove Science Behind PEEK-on-PEEK(TM) Technology for Motion Preservation Devices
4. Many Breast Cancer Patients Are Not Receiving Most Advanced Breast Conserving Surgical Techniques, New Study Finds
5. STAAR Surgical Reports 33% Third Quarter Revenue Growth
6. New National Patient and Surgeon Surveys Show Post-Surgical Care Critical to Optimal Weight Loss After Bariatric Surgery
7. An analysis of the surgical and perioperative complications in right hepatectomies
8. Surgical technique halts cell loss, Parkinsons researchers find
9. Dr. Lisa Zdinak Announces, CO2TouchTM Brazilian Carboxytherapy - New Technology for Non-Surgical Treatment of Stretch Marks, Cellulite and Dark Undereye Circles
10. Older Adults Reluctant to Question Surgical Treatment
11. Study shows that surgical weight loss does not eliminate obstructive sleep apnea
Post Your Comments:
(Date:6/26/2016)... ... , ... On June 10-11, 2016, A Forever Recovery, a holistic treatment center ... Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. This annual ... the world’s leading providers of cereal and other breakfast foods. Its residents often refer ...
(Date:6/26/2016)... Birmingham, Lake Orion, Clarkston, Michigan (PRWEB) , ... ... ... their direction with respect to fertility once they have been diagnosed with endometriosis. ... for tolerable intercourse but they also require a comprehensive approach that can help ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, ... Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms ... Final Cut Pro X . Simply select a ProHand generator and drag it above ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health ... of their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards ... at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort ... holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain ... Disease (SCD) is a disorder of the red blood cells, which can cause episodes ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... report to their offering. ... failure, it replaces the function of kidneys by removing the ... the treatment helps to keep the patient body,s electrolytes such ... Increasing number of ESRD patients & substantial healthcare expenditure on ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Global MEMS Devices Medical Market Analysis 2016 - Forecast to ... The report contains up to date financial ... reliable analysis. Assessment of major trends with potential impact on ... dive analysis of market segmentation which comprises of sub markets, ...
Breaking Medicine Technology: