Solviva® is a family of biomaterials offered for use in implantable medical devices. Only products designated as part of the Solviva® family of biomaterials may be considered as candidates for medical applications implanted in the human body and devices that are in contact with bodily fluids or tissues for greater than 24 hours.
Solviva Biomaterials meet or exceed the highest industry standards in terms of quality and biological safety. Products are available for prolonged exposure (greater than 24 hours to less than 30 days) and permanent exposure (greater than 30 days) to bodily fluids and tissue in the human body.
Solviva products can be sterilized using all conventional sterilization methods, including gamma radiation, ethylene oxide and steam.
The Solviva family of biomaterials includes four distinct polymer chemistries, providing more options for meeting the needs of implantable devices used in orthopedics, cardiovascular, spine and more.
Zeniva® polyetheretherketone (PEEK) is one of the most biostable plastics available with high strength and stiffness plus excellent toughness and fatigue resistance. Zeniva PEEK meets the requirements of ASTM F2026-07 as a polyetheretherketone (PEEK) polymer for surgical implant applications.
Proniva® self-reinforced polyphenylene (SRP) is among the world's stiffest and strongest unreinforced thermoplastic that offers exceptional biocompatibility and hardness.
Veriva® polyphenylsulfone (PPSU) provides unsurpassed toughness combined with transparency and excellent biocompatibility.
Eviva® polysulfone (PSU) offers practical toughness in a strong, transparent polymer. It is also available in opaque white.
Solviva Biomaterials are available directly from Solvay in both injection molding resins and stock shapes. Please contact us for individual data sheets.
Solvay Specialty Polymers and Secant Medical®, a leading manufacturer of custom biomedical textile structures for medical devices, have formed a marketing partnership to promote the development and production of implantable biomedical fabric structures made of Zeniva® PEEK (polyetheretherketone) fiber.
The collaboration will result in the formation of a new supply chain that will provide medical OEMs with options to develop custom implantable fabrics made of Zeniva PEEK for therapeutic devices in orthopedics, cardiovascular, tissue engineering, neurology, and general surgery.
The partnership further solidifies Solvay’s position as a strategic materials supplier to the healthcare industry and expands Secant Medical’s leadership position in biomedical textiles engineering.
Secant Medical uses high-performance metallic and polymeric biomaterials in various combinations to manufacture a range of woven, knitted, and braided fabrics for implantable devices. Custom applications include high-strength sutures, bone anchoring devices, rotator cuff and arthroscopic joint repair, spinal stabilization and disc repair and replacement, textile-based heart valves and vascular grafts, and lightweight textile mesh structures for a variety of surgical procedures that require tissue reinforcement and wound support.
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Solvay Specialty Polymers Biomaterials News
November 12, 2014
Solvay’s Extensive Portfolio of Advanced Polymers Meets Growing Demand from Instrumentation to Implant
October 1, 2014
France's Sophysa Uses Solvay's Eviva® PSU in Implantable Brain Shunts and Access Ports
June 11, 2014
Extremity Medical Receives FDA Clearance for New Hammertoe Anchor Implant Made of Solvay’s Zeniva® PEEK
March 4, 2014
Solvay Specialty Polymers to Host Healthcare Educational Summit at AAOS Meeting in New Orleans
December 5, 2013
Novel Revivent™ Myocardial Anchoring System from BioVentrix Uses Solvay's Zeniva® PEEK in Tether Component
December 4, 2013
Solvay Specialty Polymers Announces Availability of Solviva® Biomaterials in Brazil
September 5, 2013
Solvay Announces Participation in 4th China International Medical Device Regulatory Forum (CIMDR)
July 25, 2013
Italy's Sintea Plustek Launches Domino Spinal Implants Made of Solvay’s Zeniva® PEEK
June 13, 2013
Italy's Plan 1 Health Uses Solvay's Eviva® PSU in Implantable Drug Infusion System
May 7, 2013
Maxim Surgical Achieves FDA Clearance for New Spinal Implants
Made of Solvay’s Zeniva® PEEK
March 19, 2013
MedShape's Novel Orthopedic Implants Are Made of Solvay’s Zeniva® PEEK
March 14, 2013
Solvay Announces TranS1 VEO® Interbody Fusion System Uses Spinal Implants Made of Solvay’s Zeniva® PEEK
January 10, 2013
Solvay Specialty Polymers Announces Availability of Solviva® Biomaterials in China
October 24, 2012
SpineNet is Granted FDA Clearance for New Cervical Cage Implants Made of Solvay’s Zeniva® PEEK
September 18, 2012
Nexxt Spine is Granted FDA Clearance for New Spinal Implants Made of Solvay’s Zeniva® PEEK
May 28, 2012
Solvay Launches New Radio Visible Grade of Zeniva® PEEK for Implantable Medical Devices
May 28, 2012
Eisertech Achieves FDA Clearance for New Spinal Implants Made of Solvay’s Zeniva® PEEK
March 14, 2012
Industry's First Totally Implantable Hearing Device Uses Solvay’s Zeniva® PEEK for Terminal Connectors
November 01, 2011
Integra LifeSciences to Use Eviva® PSU in Brain Shunt Valves
July 14, 2011
RōG Sports Medicine Achieves FDA Clearance for New Suture Anchor Implant Made of Zeniva® PEEK
June 14, 2011
Marketing Partnership with Secant Medical® in Biomedical Fabrics
May 23, 2011
Apollo Spine Inc. Achieves FDA Clearance for New Spinal Implants Made of Zeniva® PEEK
April 12, 2011
DiFUSION Technologies' New Interbody Implants Are Made of Zeniva® PEEK
February 04, 2011
Nobel Biocare's Dental Healing Caps are Molded of Solvay’s Eviva® Polysulfone for Toughness and Biocompatibility
January 12, 2011
Solvay Achieves ISO Certification for Solviva® Biomaterials
October 05, 2010
AVS Wins FDA Clearance for New Spinal Implant Made of Zeniva® PEEK
Only products of Solvay Specialty Polymers USA, LLC designated as part of the Solviva® family of biomaterials may be considered as candidates for medical applications implanted in the human body and devices that are in contact with body fluids or tissues greater than 24 hours.
Solvay has not performed clinical medical studies of the use of these medical grade and products. Moreover, Solvay has neither sought, nor received, approval from the Food and Drug Administration (FDA) for their use in implants in the human body or in applications in which there is contact with body fluids or tissues.
The suitability of these Solviva® grade products in a given end-use environment is dependent upon various conditions including, without limitation, chemical compatibility, temperature, part design, sterilization method, residual stresses, and external loads. It is the sole responsibility of the manufacturer of the final product, and not Solvay, to determine the suitability (including biocompatibility) of all raw materials and components, including any Solvay product, in order to ensure that the final product:
It also is the sole responsibility of the manufacturer of the final end use product to conduct all necessary tests and inspections and to evaluate the final product under actual end-use requirements and to adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks.
Any decision regarding the appropriateness of a particular medical product in a particular clinical application should be based on the judgment of the manufacturer, seller, the FDA, and the treating physician. Do not rely upon Solvay. Solvay cannot weigh the benefits against the risks of a medical device and cannot offer a medical judgment on the safety or efficacy of the use of a Solvay product in a medical application.
The sterilization method and the number of sterilization cycles a medical device can withstand will vary depending upon type/grade of product, part design, processing parameters, sterilization temperature, and chemical environment. Therefore, the manufacturer of the end use final product must evaluate each device to determine the sterilization method and the number of permissible sterilization cycles appropriate for actual end use requirements and must adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks.
Solvay may contractually agree to provide existing test data and other information about its products or to perform new testing of the products. Such information is to be provided, and such services are to be performed, only pursuant to a written agreement that requires the manufacturer of the end use final product to accept full responsibility for defining the scope of testing and determining the adequacy and appropriateness of the testing for the end use. Such data and information are only preliminary and are not meant to assure the biocompatibility or suitability for use of these products as actually used in the final end use product and do not relieve the manufacturer of its responsibility to properly evaluate its final end-use product under actual end use requirements, nor does it relieve the manufacturer of any of its other responsibilities described in these Guidelines.
Solvay does not warrant or represent that single-use medical devices made from a Solvay medical grade product are suitable for multiple uses. If the medical device is reprocessed and/or labeled for multiple uses, it is the responsibility of the reprocessor and/or manufacturer to determine the appropriate number of permissible uses by evaluating the device under actual sterilization, cleaning, and end-use conditions and to adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks.
If the FDA requires proprietary information about any Solvay Product as part of the 510(k) clearance or premarket application (PMA) approval process for the manufacturer's end-use final product, Solvay may establish a Drug or Device Master File and grant a right of reference to it, in order to allow FDA to review such information without disclosing Solvay's proprietary information to the manufacturer. An authorization to reference a Master File shall only be established pursuant to a written agreement with manufacturer.
There is a risk of failure and adverse consequences with all medical devices, including devices implanted in the human body and devices that are in contact with body fluids or tissues.
SOLVAY MAKES NO REPRESENTATION, PROMISE, EXPRESS WARRANTY OR IMPLIED WARRANTY (INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY USE AS MAY BE CONTEMPLATED) CONCERNING THE SUITABILITY OF ANY SOLVAY PRODUCT FOR USE IN MEDICAL APPLICATIONS, INCLUDING AN IMPLANT IN THE HUMAN BODY OR IN APPLICATIONS IN WHICH THERE IS CONTACT WITH BODY FLUIDS OR TISSUES. NO SOLVAY REPRESENTATIVE HAS THE AUTHORITY TO MAKE ANY ORAL REPRESENTATION THAT CONFLICTS WITH ANY PORTION OF THESE GUIDELINES.
If the purchaser of any Solvay products is not the manufacturer of the final end use product, it is the responsibility of the purchaser to forward these Guidelines to such manufacturer.
The entire line of Solviva Biomaterials is manufactured in compliance with ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Solvay’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant.
Solviva Biomaterials, as medical device raw materials, are considered biocompatible based on the requirements of ISO 10993-1:2009 for long term implants. Detailed Master Access Files (MAF) are registered with the FDA to support our customer’s submissions for regulatory clearance.
For more information regarding biocompatibility testing of Solviva biomaterials, please contact us.