SaluCartilage is a synthetic implant developed to replace worn-out cartilage surfaces, restoring mobility and relieving joint pain. The damaged articular cartilage may be cored out and replaced with SaluCartilage to provide a smooth, load-bearing joint surface.

This procedure offers a less invasive and more cost-effective alternative to current therapies for patients suffering from arthritis and/or sports injury. SaluCartilage is cleared for sale in the European Union and Canada. Preparation of the FDA submission required for sale in the US is on-going.

Indications for Use:
SaluCartilage is indicated for use in treatment of painful chondral or osteochondral defects of the articular cartilage surface.

Description:
A non-resorbable, cylindrical device made from Salubria biomaterial, SaluCartilage can replace small lesions of damaged cartilage to restore a cushioning, load-bearing articular surface. This organic polymer-based material is capable of withstanding repetitive loading typical of normal walking conditions, and its mechanical properties are similar to the articular cartilage in the knee. Composed of synthetic Salubria biomaterial, SaluCartilage provides an alternative to tissue-based treatments without exposing the patient to the risk of viral infection because it does not contain substances derived from human or animal tissue.

Procedure:

SaluCartilage is intended for use during a single minimally invasive mini-open or arthroscopic surgical procedure, and is designed to be compatible with standard instrumentation. The SaluCartilage implantation procedure is similar to that used for osteochondral autograft or allograft transplantation; the implant is placed into a cored-out hole to resurface the damaged area of cartilage.

SaluCartilage being implanted in Knee.

Product Offering:
SaluCartilage is provided in a range of diameters to allow for complete filling of the defect. Each SaluCartilage implant is supplied individually packaged, sterile and hydrated in saline for presentation onto the operative field.

Abbreviated References:
1. Bosch U, Meller R, Tröger JH, et al. SaluCartilage-a synthetic cartilage replacement for the minimally invasive treatment of osteochondral defects. Arthroscopie. 2003;16:40-43.
2. Falez F, Sciarretta FV. Treatment of osteochondral symptomatic defects of the knee with SaluCartilage. Journal of Bone and Joint Surgery - Br. 2005;87-B(SUPP II):202.
3. Koh JL, Marcu D, Anderson DR, et al. Osteochondral resurfacing with a hydrogel implant: A biomechanical analysis in a porcine model: Feinberg School of Medicine: 1-15.
4. Maiotti M, Massoni C, Allegra F. The use of poli-hydrogel cylindrical implants to treat deep chondral defects of the knee. Arthroscopy Association of North America. Vancouver, B.C.; Apr 2005.
5. Swieszkowski W, Ku DN, Bersee HE, Kurzydlowski KJ. An elastic material for cartilage replacement in an arthritic shoulder joint. Biomaterials. 2006 Mar;27(8):1534-41. Epub 2005 Sep 26

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Q: Is SaluCartilage available in my area? How can I order it?
A: SaluCartilage is cleared for sale in Canada and the European Union. Click here for a list of regional distributors.

Q: What sort of testing has been done to demonstrate the safety and effectiveness of SaluCartilage?
A: SaluMedica has conducted a myriad of mechanical, biocompatibility and pre-clinical testing. Additionally, data from the first years of clinical use are being compiled for publication.

Q: For what problems is SaluCartilage indicated?
A: SaluCartilage is intended to treat chondral or osteochondral defects of the articular cartilage surface. SaluCartilage is not indicated for degenerative joint disease or for areas of damaged that would require more than two implants.

Q: How is SaluCartilage implanted?
A: SaluCartilage implants are inserted in a minimally invasive mini-open procedure similar to the second part of an osteochondral autograft transfer (i.e. no osteochondral harvesting is required).

Q: Is SaluCartilage resorbable?
A: No. SaluCartilage is biostable so it will not degenerate under demanding joint forces.

Q: Does SaluCartilage allow for tissue or bone ingrowth?
A: No tissue or bone ingrowth into the material of SaluCartilage has been observed.

Q: How does SaluCartilage stay in place?
A: SaluCartilage is designed to be placed with an interference fit. It has been observed that a “collar” of subchondral bone forms over the early implantation period. This may occur because the material transmits load to the underlying bone, and a new layer of subchondral bone is formed in response to the load compression (Wolff’s Law) that surrounds and collars the implant.

Q: What is Salubria?
A: Salubria biomaterial is SaluMedica’s patented platform technology. The main components of Salubria hydrogel are saline and a highly biocompatible polymer that has been used for years in contact lenses. There are no toxic, chemical cross-linking or active agents used in the production of Salubria.

Q: Can SaluMedica make different sizes of SaluCartilage?
A: Yes. SaluCartilage can be manufactured in additional sizes. SaluCartilage is currently available outside the U.S. in 10 and 15 mm diameters (both 10 mm in length), and 6 and 8 mm diameters (both 8 mm in length).

Q: How long will it be before SaluCartilage is available in the US?
A: SaluMedica has not submitted SaluCartilage to the FDA for regulatory review. The Company makes no claims as to the date of submission or to when the product might be available in the US.

Q: What is your long-term clinical data on SaluCartilage?
A: Long-term clinical data is currently being compiled for publication. Several clinical abstracts have been linked to the SaluMedica web site for reference.

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www.cartilage.org
orthopedics.about.com/cs/kneeinjuries
sportsmedicine.about.com/cs.knee_injuries
arthritis.about.com
www.knee1.com
www.body1.com
www.arthritis.org
www.arthritis.com
www.arthroscopy.com/sp05000.htm
www.medicinenet.com
www.medicineonline.com
www.orthoguide.com
www.aaos.org
www.ama-assn.org
www.healthfinder.gov
www.nih.gov/niams


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SaluCartilage has received the CE Mark allowing for distribution in the European Union and the Medical Device License from Health Canada allowing for distribution in Canada. SaluCartilage is not cleared by the FDA for distribution in the United States.

If you are a medical facility in the European Union or Canada wishing to purchase product, click here to find your regional distributor. If your area is not currently covered by SaluMedica's distribution network, please contact SaluMedica.

Distributor Interest Form: Complete the form below if you are a distributor who would like to be considered or added to SaluMedica’s database for future distribution opportunities >Distributor Interest Form

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