Navigation Links
Simplify Medical Announces CE Mark for New MRI Compatible Cervical Artificial Disc
Date:2/17/2015

MOUNTAIN VIEW, Calif., Feb. 17, 2015 /PRNewswire/ -- Simplify Medical, Inc. is pioneering disc arthroplasty with a non-metal, MRI friendly cervical artificial disc.  The Company announced today that it received a CE mark for its Simplify DiscTM. CE Mark allows for marketing and commercialization in the European Union and additional countries that accept the CE Mark. ISO13485 certification was obtained in 2008.  Simplify Disc is a cervical disc replacement composed of MRI friendly materials designed to eliminate invasive CT scans, reduce radiation exposure, and provide a metal-free option to patients.  Simplify Disc has endplates designed to be more compliant with the vertebral bodies under loading common to the cervical spine and includes disc heights as small as 4mm for smaller patient anatomy.

"The CE Mark represents a significant achievement for Simplify Medical, enabling us to commercialize our Simplify Disc internationally and expand upon our successful clinical experience that served as the basis for approval," said Simplify Medical CEO, David Hovda. "Because we have MRI friendly, durable materials using advanced medical polymers and ceramic, we can provide a metal-free solution to surgeons and patients.  MRI imaging is the most accurate option for evaluating soft tissue in the spine, non-invasive for patients, and avoids ionizing radiation and contrast injections associated with CT/Myelograms."   

Simplify Disc enables range of motion similar to intact natural discs, while providing lower disc heights to treat patients with smaller anatomy, and a streamlined implantation procedure. Simplify Medical expects to begin a U.S. IDE clinical study in 2015, leveraging its considerable motion preservation experience and clinical data.   

Simplify Cervical Disc
The Simplify Disc is an MRI compatible artificial disc composed of MRI friendly materials utilizing advanced polymers and ceramic, eliminating the need for radiation-intensive CT/Myelograms. The PEEK-on-ceramic articulation is designed for low levels of wear to optimize long-term durability, and Simplify Disc offers low height implant options for patients with smaller cervical disc spaces for whom larger implants are not optimal.  

About the Artificial Disc Market
The Journal of Orthopaedic Sports Physical Therapy (2008;38(9):A1-A34) reports that 22-70% of the population will have neck pain at some point in their lives with chronic neck pain of greater than 6 months duration affecting 14% of individuals with neck pain.  Neck pain is second only to low back pain in annual workers' compensation costs in the U.S.

About Simplify Medical
Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative MRI friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Mountain View, California. To learn more, visit our website at www.simplifymedical.com

Caution:  the Simplify Disc is an Investigational device in the United States and is limited by law to investigational use.  

Logo - http://photos.prnewswire.com/prnh/20150129/172439LOGO

 


'/>"/>
SOURCE Simplify Medical, Inc.
Copyright©2015 PR Newswire.
All rights reserved

Related medicine technology :

1. Implantable Medical Device Group formed to Reduce Risk and Simplify Management of Active Implant Projects
2. Simplifying the Bioequivalence Testing Process and Optimizing Oral Formulation Development via Unifying the Global Life Science Community this November in San Diego
3. Vasomedical Announces Financial Results for the First Quarter of 2013
4. CCS Medical Moves Forward as Medicare Winner
5. PENTAX Medical Launches Industrys Highest* Resolution HD+ Imaging Technology For Flexible Endoscopy
6. SOAPware President Randall Oates, M.D. Among First NCQA Certified Patient-Centered Medical Home Content Experts
7. RAD Technology Medical Systems Delivers Innovative Time Saving Modular Construction At New Swedish Cancer Institute Facility
8. PENTAX Medical And Hitachi-Aloka Medical Continue Joint Innovation And Global Leadership In Endoscopic Ultrasound Systems
9. ACLS Online Course Manuals are Now Available at No Cost through United Medical Education
10. Statistical Challenges in Medical Device Trail Evaluation
11. Claret Medical, Inc. Announces Publication of the First Clinical Research on the Frequency and Composition of Embolic Debris Captured during TAVR
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/11/2019)... ... September 11, 2019 , ... ... today the launch of Annatto-GG™ 150 , a revolutionary compound that supports ... (geranylgeraniol), a patented form found in nature through the annatto plant, it’s a ...
(Date:9/11/2019)... , ... September 11, 2019 , ... Abilene Christian University ... of Nursing Practice (DNP) degree. The online BSN to DNP program pathway is meant ... Bachelor’s of Science in Nursing (BSN) degree to a Doctor of Nursing Practice degree. ...
(Date:9/11/2019)... ... 2019 , ... This event is free and takes place on Saturday, September ... 4 p.m. The Foundation for Senior Services Wellness Expo will feature entertainment and educational ... in a variety of fields. , The mission of the Foundation for Senior ...
Breaking Medicine Technology:
(Date:9/11/2019)... ... 2019 , ... Women’s Excellence is excited to announce the opening of their ... Suite 103, Royal Oak, MI 48073 in the heart of Royal Oak off Woodward ... services in a contemporary, spa-like atmosphere. We are thrilled to be in a ...
(Date:9/11/2019)... ... September 10, 2019 , ... Episcopal Relief & ... vulnerable communities impacted by Hurricane Dorian. , In partnership with the Episcopal ... of Georgia, and the Episcopal Farmworker Ministry, Episcopal Relief & Development is giving ...
(Date:9/9/2019)... ... September 09, 2019 , ... Sharon, the respected Practice Administrator ... of Dental Office Management (AADOM) Annual Conference. This year, esteemed dentist, Dr. Patrick ... is Sharon’s third nomination in a row. The entire team at Cieplak Dental ...
(Date:9/9/2019)... NEW YORK (PRWEB) , ... ... ... Center of NYC ( https://www.orthodonticscenternyc.com ) located on the Upper East Side ... division to their busy orthodontic practice. The pediatric orthodontic division specializes in ...
(Date:9/8/2019)... ... , ... The reviews from patients of ABM Medical Clinic who have had ... pain free fat loss system, has patients booking their sessions and recommending this procedure ... state of the art technology incorporating radio frequency and heat to rid the fat ...
Breaking Medicine News(10 mins):