Pitch-Patch
Tissue Reinforcement
Device

Rotator Cuff Repair – Confident Solutions

Pitch-Patch Tissue Reinforcement device is a non-absorbable, sterile, polyester, open-weave textile with reinforced borders and suture holes.

  • 355N Tensile Strength

  • Long History of Medical Use

The Pitch-Patch is a permanently implantable device constructed from non-absorbable poly (ethylene terephthalate) fibres (polyester), a knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, these are 30 x 20 mm and 35 x 25 mm, respectively and is supplied sterile.

Polyester implants have a long history of routine use in joint surgery. They are well tolerated and show little foreign body tissue reaction. Unlike biological tissue, the polyester material used for Pitch-Patch does not cause any immunological reaction. Testing of this special design has shown a very high average strength of over 355 N for the standard patch.

Pitch-Patch can be applied using an open or arthroscopic technique for the reinforcement of the rotator cuff. Pitch-Patch is not intended for stand-alone bridging (replacement of the cuff with insufficient closure).

INDICATIONS

The Pitch-Patch Soft Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons. The Pitch Patch Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

HOW DOES IT WORK?

For Rotator Cuff Reinforcement:

  1. The surgeon repairs the rotator cuff with his/her preferred technique.
  2. Pitch Patch is sutured to the repaired rotator cuff tendon using a combination of free sutures and soft tissue anchors.
  3. The Pitch Patch device augments the tissues natural strength and function through the healing process.
  4. See the Pitch Patch Instructions for Use (IFU) and Surgical Technique Manual (STM) for additional information and instruction.

Although most patients benefit from current techniques of RC repair, retears remain the biggest problem after surgery. Hence, considering the high costs associated with surgical intervention followed by lengthy rehabilitation, there is a constant need to devise better ways to avoid construct failure and consecutive revision surgery.2,3

In radiologic follow-up, the Leuzinger, et al, study showed that the retear rate of 14% compares favorably with the existing literature in standard nonaugmented RC repairs.1

Order Codes

  • 102 -1090 Pitch-Patch Tissue Reinforcement, Standard (30 mm x 20 mm) (sterile, single-use)
  • 102 -1091 Pitch-Patch Tissue Reinforcement, X-Large (35 mm x 25 mm) (sterile, single-use)

FEATURES AND BENEFITS

  • High strength construct of polyester to augment Rotator Cuff Repairs
  • Surgical techniques for Arthroscopic and Open procedures
  • Polyester has a long history of safe and efficacious use in surgical procedures
  • Predetermined elongation which is anatomically aligned
  • Woven polyester implant utilizes medical manufacturing techniques supported by over 30 years of data
  • Open-weave allows tissue ingrowth
  • Reinforced eyelets to prevent suture pull-through
  • Flexible technique to accommodate anatomic variations

Product Documents

CONTRAINDICATIONS

  • Do not use Pitch-Patch as a bridging device.
  • Do not use Pitch-Patch if there is any evidence of infection.
  • Do not use Pitch-Patch in patients with known hypersensitivity to implant materials. If the patient is suspected of having any foreign body sensitivity, appropriate tests must be made prior to implantation.
  • Do not use Pitch-Patch in patients who are skeletally immature. It will not elongate as the patient grows.

Additional Information

Please note: Regulatory approval for products mentioned on this website varies from country to country. For further information, and for details of local distributors and agents, contact our Sales and Marketing team at enquiries@xirosna.com. All data listed on this page is held at Xiros and can be requested by contacting enquiries@xirosna.com.

To request the full range of product documentation or to view any of these documents in a language other than English, please contact us for availability. Always refer to the Instructions for Use for detailed information and essential warnings and precautions.

  • 1. Daniel Smolen, MDa,b, Nicolas Haffner, MDb,c, Rainer Mittermayr, MDb,d,*, Florian Hess, MDe, Christoph Sternberg, MDa, Jan Leuzinger, MDa; Application of a new polyester patch in arthroscopic massive rotator cuff repair – a prospective cohort study; J Shoulder Elbow Surg (2020) 29, e11-e2. https://doi.org/10.1016/j.jse.2019.05.015

aEtzel Clinic, Pfaeffikon, Switzerland
bLudwig Boltzmann Institute for Experimental and Clinical Traumatology, Vienna, Austria
cOrthopedic Hospital Gersthof, Vienna, Austria
dTrauma Center of the Workmen Compensation Board, Vienna, Austria
eDepartment of Orthopedic Surgery and Traumatology, Kantonsspital Frauenfeld, Frauenfeld, Switzerland
*Reprint requests

  • 2. Iyengar JJ, Samagh SP, Schairer W, Singh G, Valone FH, Feeley BT. Current trends in rotator cuff repair: surgical technique, setting, and cost. Arthroscopy 2014;30:284-8. https://doi.org/10.1016/j.arthro.2013.11.018
  • 3. Mather RC, Koenig L, Acevedo D, Dall TM, Gallo P, Romeo A, et al. The societal and economic value of rotator cuff repair. J Bone Joint Surg Am 2013;95:1993-2000. https://doi.org/10.2106/JBJS.L.01495