Patient Informations

Product Description

The Matrix Patch equine from Autotissue Berlin GmbH is a cell-free tissue patch which is obtained from the horse’s pericardium (so-called equine pericardium).

Biological implants derived from animals cannot be used in humans without appropriate pre-treatment due to rejection reactions. Glutaraldehyde has been used for the treatment of biological animal materials for over 50 years. However, this chemical has some serious disadvantages. Firstly, it is highly toxic and therefore cannot be used in the operating theatre in Europe today. Secondly, all biological tissues treated with glutaraldehyde tend to shrink and calcify over time. This second disadvantage is especially a problem when using glutaraldehyde-treated material in childhood, because here all metabolic processes take place at a high speed. Shrinkage and calcification can therefore lead to loss of function of the biological implant in the growing child within a few years, sometimes even within a few months.

An alternative to tissue treatment with glutaraldehyde is the so-called decellularisation. In a complex process, all cells are removed from the animal tissue. Essentially only the supporting tissue of collagen and elastin remains. Collagen is responsible for the stability and elastin for the elasticity of the tissue. Without cells, the tissue originating from the animal can be implanted in humans without causing rejection reactions. Shrinkage and calcification, as they occur in biological material treated with glutaraldehyde, have not been observed so far. The equine pericardial patch available from Autotissue Berlin has been commercially available since 2011 and has so far been used more than 8,000 times worldwide.

Scope of the Matrix Patch equine

The Matrix Patch equine from Autotissue Berlin is a versatile product for use in heart surgery. It can be used to repair constricted vessels, close holes in the heart and reconstruct heart valves.

Follow-up Examinations

The Matrix Patch equine from Autotissue Berlin does not require any special follow-up examinations. Required follow-up examinations are mainly due to the existing heart defect, even if it has been corrected surgically.

If you have any questions regarding necessary follow-up examinations for your heart defect, please contact your attending physician.

Symbols on the Implant Card

You have probably received an implant passport from your physician. This passport contains various ISO-certified symbols that are intended to be internationally understood. These are in detail:

2610-Patient-number

Patient Name or Patient ID

5662-Date

Date of Implantation

Name-and-Address-of-the-implanting-healthcare-institution-provider

Name and Address of the Implanting Healthcare Institution / Provider

3082-Manufacturer

Name and Address of the Manufacturer

3705-Patient-information-website

Information Website for Patients

Device-name

Device Name

2498-Serial-number

Serial Number

2492-Batch-code

Lot Number / Batch Code

UDI

Unique Device Identification (UDI) is a worldwide system for uniform product identification for medical devices. The UDI system was commissioned by the US Food and Drug Administration (FDA) to improve patient safety and is intended to simplify product recalls and optimize market surveillance.

Lost of the Implant Card

If you lose your implant passport, please contact the clinic where the Matrix Patch equine was implanted. Due to data protection guidelines, Autotissue Berlin does not have any information about patients who have been implanted with the Matrix Patch equine.

Periodic Safety Update Report

The periodic safety update report (PSUR) is an annual report that serves to update the risk-benefit balance of drugs or medical products. Manufacturers of medicinal products are obliged by law to evaluate adverse drug reaction reports collected worldwide and to check whether they result in measures regarding the safe use of the medicinal product, i.e. whether further restrictions on use or additional adverse drug reactions must be taken into account.

The PSUR is subjected to an assessment by a notified body, which examines the content of the submitted data and evaluates the conclusions of the medical device manufacturer. If necessary, the product information texts, i.e. the summary of the characteristics of the medical device (corresponding to the technical information) and the package leaflet are amended accordingly.

PSURs are an instrument of the drug safety system in the European Union.

For further questions please contact info(at)autotissue.de or use or contact form.