Navigation Links
Pioneer(R) Surgical Technology's NuBac(R) Nucleus Replacement Device Wins FDA Approval for IDE Pivotal Study
Date:10/30/2008

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:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh in Abilene, Texas, ... real facts surrounding all those Bible stories. For generations families have gathered to hear ... says there is more to these than just mere “stories”. , The article ...
(Date:2/12/2016)... ... ... of restorative dentistry, to date there has been no other option in the U.S. to ... is a now a new protocol in stopping cavity progression; Silver Diamine Fluoride (SDF). ... The application is as simple as drying the tooth and applying the SDF to ...
(Date:2/11/2016)... ... February 11, 2016 , ... “ HEALING MIND : ... Well Managed Mind” (published by Balboa Press) teaches readers how to become their own ... profound love, author Janice McDermott, M.Ed., LCSW, offers an understanding of how to heal ...
(Date:2/11/2016)... Oregon (PRWEB) , ... February 11, 2016 , ... ... campus participated in the American Osteopathic Association’s (AOA) Match Program Tuesday, February 9, ... Match Program places students into osteopathic graduate medical education positions across the country. ...
(Date:2/11/2016)... ... February 11, 2016 , ... Florida Hospital presents Heart Health Awareness ... St. Louis Blues at the Amalie Arena. The puck drops at 6:00pm, but fans ... the MEGA Heart, prior to the game. The MEGA Heart will be located on ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... 2016  NOIT™ Research LLC, a private, leading-edge autism ... campaign to assist needy families in obtaining one of ... between February 10, 2016 and March 31, 2016, the ... The NOIT is an auditory stimulus that plays a ... skills. Beth Shier , NOIT Research ...
(Date:2/11/2016)... Conn. , Feb. 11, 2016  AfterPill.com is ... to recommend alcohol abstinence for all women who are ... in the U.S. each year and raises the risks ... --> --> According to the Guttmacher ... 70% of women of child-bearing age, who have sex ...
(Date:2/11/2016)... Iowa , 11 de fevereiro de 2016 ... inauguração de sua fábrica de soroalbumina bovina (BSA ... Zelândia. A fábrica fica na Ilha Norte da ... "), desenvolvido e estabelecido na fábrica da Proliant ... . O projeto e instalação dos equipamentos ...
Breaking Medicine Technology: