Navigation Links
Intelligent Implant Systems Receives 510(k) Clearance for Two-Level Revolution™
Date:4/29/2016

Intelligent Implant Systems announced today that the two-level components for the Revolution™ Spinal System were cleared by the FDA via 510(k) for sale in the United States. These components expand the capabilities of the system and allow Revolution™ to be utilized for two-level posterior thoraco-lumbar fusions. With one-level sales beginning in October of 2015, the company has seen significant sales growth in 1Q 2016, and the system is currently being used at both hospitals and ASC’s in several regions across the United States. Revolution™ is intended to simplify single and two-level thoraco-lumbar fusions by providing a sophisticated novel implant system which is implanted with a single tray of all-sterile instruments. Implants are also provided sterile, eliminating the need for the hospital or ASC to sterilize anything for the procedure. The procedure is fast: place the pedicle screws, attach the connectors, and lock with the single-use torque wrench. There are no rods to contour, and with the locking mechanism built in, there are no set screws to place and potentially cross-thread.

Marc Richelsoph, CEO of Intelligent Implant Systems said: “Intelligent Implant Systems is committed to expanding our pioneering efforts in the all-sterile lumbar implant market. With the addition of the two-level components, the potential usage of the implant system now applies to the majority of patients, as most fusions are one and two-level. The same benefits of the system apply to the hospital and ASC: a simplified procedure, one tray of single-use instruments to make the procedure faster, and a potentially reduced risk of infection for the patients. OR turn time can be accelerated, as there is no need to clean and sterilize instruments, and there is no need for inventory management by the hospital or ASC.”

The new components allow expansion to two-level fusions while maintaining the simplicity and existing capabilities of the Revolution™ system. The same single-use instrument tray is used for a one or two-level procedure. The two-level system utilizes the existing Revolution™ Connectors, and requires only a minimum of additional components. The unique and extremely controllable compression and distraction provided by the system is maintained, setting the system apart from any other system on the market. All implants are UDI compliant, with individual bar coding and labels to provide inventory and tracking information.

About Intelligent Implant Systems:

Based in Charlotte, North Carolina, Intelligent Implant Systems was founded with the goal to develop and market innovative surgical solutions for orthopedics and both fusion and non-fusion applications of the spine. Since its inception, Intelligent Implant Systems has been granted multiple US patents with foreign and additional US patents pending to protect its core technology. The product portfolio includes implants and instrumentation for enhanced fixation technology. Distribution is handled by our independent sales force, which continues to expand.

Read the full story at http://www.prweb.com/releases/2016/04/prweb13379027.htm.


'/>"/>
Source: PRWeb
Copyright©2016 Vocus, Inc.
All rights reserved


Related biology technology :

1. Finesse Solutions Introduces SmartParts for Intelligent Universal Controllers
2. Intelligent Implant Systems Announces 510(k) Clearance of the Marauder Cervical-Thoracic Spinal System
3. Olea Announces Revolutionary New OS-3001 Intelligent Multi-Sensor Platform
4. Intelligent Implant Systems Announces Debut of All-Sterile Posterior Spinal System
5. New Version of iSense, the Accompanying Software for the Intelligent Sensor Management (ISM®) Technology from METTLER TOLEDO
6. Intelligent Implant Systems Announces US Patent Attained for Revolution™ Spinal System
7. Intelligent Implant Systems Announces Funding
8. New Retractable Sensor Housings with Intelligent Locking System from METTLER TOLEDO
9. Global Bio-implants Market 2012-2016 New Research Report Now Available at MarketResearchReports.biz
10. Nebraska Medical Center Implants States First SynCardia Total Artificial Heart
11. Patti Flint MD, A Top Female Plastic Surgeon in the Southwest, Is Proud To Offer Cutting-Edge 3D Crisalix Technology to Patients When Selecting Breast Implants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/8/2019)... ... January 08, 2019 , ... The American Society of Gene ... named by a selection committee made up of industry leaders identified by the ASGCT ... grants are mentored awards created to support ASGCT members designing transformative pilot studies in ...
(Date:1/4/2019)... ... January 02, 2019 , ... ... and cancer cells in blood, has been named as a partner in Medigen ... company developing cell therapies for cancer treatment, will use CellMax Life’s circulating tumor ...
(Date:12/19/2018)... ... 19, 2018 , ... RURO, Inc., a leading provider of ... 7.1. The new release enhances the latest version of Limfinity®, RURO’s software framework, ... end. , Validation protocols, and their execution, are critical for software systems scrutinized ...
(Date:12/14/2018)... ... 14, 2018 , ... NOVA OCULUS PARTNERS, LLC, and its ... to immediately begin a clinical patient trial in Edmonton using their pioneering technology ... Canada has granted what is called an Investigational Testing Authorization for the trial, ...
Breaking Biology Technology:
(Date:1/10/2019)... ... , ... When Dr. James L. Sherley, M.D., Ph.D., founder and director of ... to the new book Perinatal Stem Cells: Research and Therapy, he knew immediately what ... secret of stem cell medicine. For more than a half-century, stem cell medicine ...
(Date:1/8/2019)... ... January 07, 2019 , ... ... and solutions for hearing instruments and specialty earphones, and Valencell , the ... hearing aid receiver in canal with an embedded biometric sensor. The BiometRIC measures ...
(Date:1/4/2019)... ... January 02, 2019 , ... ... particularly noteworthy, as the life science tools and service supplier turned 40 in ... a catalog. The catalog features not just part numbers like most catalogs, but ...
Breaking Biology News(10 mins):