DEVICE MANUFACTURERS

Your partner in emerging medical technology

Discover some of the game-changing innovations made possible by our biomaterials

Developing next-generation ortho devices

From applications such as cranio-maxillofacial implants, catheter-based interventions printed implantable electrodes and extremity emerging arthroplasty devices, our metal-replacement solutions are focused on improving long-term clinical outcomes and patients’ lives.

Meeting the needs of medical device companies, surgeons and patients

Invibio is committed to developing solutions that can bring significant advantages for patients and surgeons. We are more than a biomaterials provider; we are a partner that can add value to all stages of a medical device product lifecycle.

Identifying New Opportunities

Utilizing multiple approaches to gain insight into patient and clinician challenges and health economic impact.

Developing Materials and Components

Developing materials, components or devices that address key challenges focusing on improved outcomes at reduced costs.

Validating Performance

Collaborating with universities and our partners to determine performance criteria and address risks.

Supporting Regulatory Processes

Partnering to identify regulatory pathways in support of fast tracking clearance.

Expediting Market Adoption

Generating clinical evidence and collaborating with KOLs to drive market adoption; offering our partners technical, marketing and sales support.

Bringing a device to market?

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Supporting Medical Innovation

See what leading healthcare professionals and the industry are saying about our biomaterial solutions

The patient’s own removed bone segments are always the first choice for implantation. However, unfortunately only a few of those re-implantations succeed, leaving the patient with a defect. To reconstruct this defect in the best way possible the surgeon uses a patient specific implant. Although the use of PEEK is relatively new in the case of cranial implants, Invibio’s PEEK-OPTIMA is proven with over 10 years of history in a wide variety of different regulatory approved devices. Their verified biocompatibility and biostability is crucial for surgeons when choosing materials

Peter Kessler
Professor
Department of Cranio-Maxillofacial Surgery
Maastricht University Medical Centre

We chose PEEK-OPTIMA because the product has a long safety record, is compatible with our manufacturing environment and is consistently available on short notice should our customers demand it

James Ketner
President & CEO
Kelyniam Global Inc.

PEEK enabled surgeon and patient benefits beyond the range provided by metallic cranial fixation devices. Surgeons can perform the procedure without instrumentation, and in addition, the Cranial LOOP is completely radiolucent – none of these are possible with metallic biomaterials. Benefits to patients include reduced risk of infection, soft tissue damage, and stress shielding or mechanical mismatch between bone and implant, and, because PEEK-OPTIMA is less likely to attach to tissue, revision surgery is easier as well.

Luís Chico
General Manager
NEOS Surgery™

It’s reset my expectations for bone healing. When I go back to using a standard implant for whatever reason, I’m disappointed. I don’t see the same healing I do when using PEEK-OPTIMA™ Ultra-Reinforced.

Adam W. Rives
Hand and Upper Extremity
Orthopedics Surgeon
Liberty Hospital

Applications

Supporting the medical industry for over a decade, our PEEK polymer solutions are proven across a range of applications

Cranio-
Maxillofacial

Active Implantable
Medical Devices

Catheter
Based Interventions

Extremities

Clinical evidence

In Vivo Biostability Study on a Polyaryletherketone Biomaterial

Developed specifically for the implant market, the unfilled (natural) material is a high strength, chemically stable and biocompatible thermoplastic polymer offered as standard, medium and low viscosity grades. PEEK-OPTIMA polymer is already being used for implants in Europe and the US.

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Interphalangeal Arthrodesis of the Toe With a New Radiolucent Intramedullary Implant (Toegrip)

Averous, et al (2015) demonstrate how a new a new generation of radiolucent implants offer a good immediate mechanical stability, adequate deformity correction, and a high rate of consolidation (83%) and patient satisfaction at 94%.

peek-optima™ Natural

PEEK-OPTIMA™ polymer blends proven performance with superior wear, safety and comfort. Since Invibio introduced PEEK-OPTIMA as the first implantable PEEK polymer in 1999, it has earned the confidence and gained the acceptance of the global medical community.

The properties of PEEK-OPTIMA™ Natural, used in specific-patient implants for cranioplasty offers many advantages over conventional materials such as Titanium and PMMA.

Eminently compatible with CAD/CAM milling processes, it offers implant fixation precision¹, strong^2-4, bio-inert and biocompatible^7,8, offers patients great aesthetic outcomes⁵ and comfort due to a lack of thermal conductivity^3,7. Surgeons benefit too with our material’s natural radiolucency with CT and MRI, allowing post-operative diagnostic imaging.^1,9,10

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References:

Hanasono, M.M. et al., (2009). Calvarial Reconstruction With Polyetheretherketone Implants. Annals of Plastic Surgery, 62(6), 653-655
Lethaus, B. et al., (2012). Cranioplasty with Customized Titanium and PEEK Implants in a Mechanical Stress Model. Journal of Neurotrauma, 29(6), 1077-1083
Scolozzi, P. et al., (2007). Complex orbito-fronto-temporal reconstruction using computer-designed PEEK implant. Journal of Craniofacial Surgery, 18(1), 224-228.
Garcia-Gonzales, D. et al., (2017). On the mechanical behaviour of PEEK and HA cranial implants under impact loading. Journal of the Mechanical Behavior of Biomedical Materials, 69, 342-354
Kim, M.M. et al., (2009). Use of customized polyetheretherketone (PEEK) implants in the reconstruction of complex maxillofacial defects. Archives of Facial Plastic Surgery, 11(1), 53-57
Zanotti, B. et al., (2016). Cranioplasty: Review of Materials. Journal of Craniofacial Surgery, 27(8), 2061-2072
Data on file at Invibio
Toth, JM. Biocompatibility of Polyaryletheretherketone Polymers. In : Kurtz, SM., ed. PEEK biomaterials handbook. Oxford : William Andrew Publishing, 75-79
Green, S. Compounds and Composite Materials. In : Kurtz, SM., ed. PEEK biomaterials handbook. Oxford : William Andrew Publishing, 75-79
Cabraja, M. et al., (2009). Long-term results following titanium cranioplasty of large skull defects. Neurosurgical Focus, 26(6), E10

News & Events

Your partner in emerging medical technology

Bringing a device to market?

In Vivo Biostability Study on a Polyaryletherketone Biomaterial

Interphalangeal Arthrodesis of the Toe With a New Radiolucent Intramedullary Implant (Toegrip)

Featured news and events

NASS 2019 Annual Meeting

US FDA clears first foot and ankle implant made from PEEK-OPTIMA™ HA Enhanced

Invibio launches JUVORA™ CAD/CAM dental disc in appealing Oyster White for US market