Indication for equine Matrix Patch™ extended

Indication for equine Matrix Patch™ extended

With effect from October 27, 2020, the indication for the equine Matrix Patch™ has been expanded. It can now also be used in adults. This indication was already approved before November 2017.

From the IFU

Intended use

The Matrix Patch™ equine pericardial patch is intended for the extension, augmentation, and repair of tissue defects during cardiovascular surgery.


Indications for use


The Matrix Patch™ equine pericardial patch is indicated for congenital and acquired disease for the extension, augmentation, and repair of defects during cardiac, arterial, and venous surgical operations such as augmentation and repair of the pulmonary artery, use as a transannular patch, reconstruction of heart valves, augmentation, and repair of veins or arteries and closure of intracardiac septal defects.


Contraindications


Since the choice of which graft material to use and the use in each patient is of utmost importance, a physician should analyze the risk/benefit ratio for the application of a pericardial patch based on the condition of each patient and his/her symptoms. 
In patients with allergies to Penicillin, Streptomycin, or Amphotericin, the Matrix Patch™ equine pericardial patch should be used only after careful consideration of the advantages of the Matrix Patch™ equine pericardial patch. In these patients, it is strongly recommended that the saline rinsing procedure, which is a standard procedure for all tissue implants before implantation, be intensified.

Supporting Literature

Matsushima S, Heß A, Lämmerzahl JR, Karliova I, Abdul-Khaliq H, Schäfers H-J. Unicuspid aortic valve repair with bicuspidization in the paediatric population. Eur J Cardiothorac Surg. 2020. Oct. 1. Online ahead of print.

Matsushima S, Giebels C, Glenske M, Karliova I, Schäfers HJ. Unicuspid valve repair-what technique, which patch for which patient? Ann Cardiothorac Surg 2019 May;8(3):430-432.

Kolesar A, Toporcer T, Bajmoczi M, Luczy J, Candik P, Sabol F. Aortic Valve Repair of a Stenotic Unicuspid Aortic Valve in Young Patients. Ann Thorac Surg 2018; 105(5): 1351-1356.