TISSUE GUARD FAMILY SURGICAL PATCHES

See Indications

35+ YEARS OF CLINICAL HISTORY

With over 30 years¹³ of global clinical history, our Tissue Guard family of surgical patches have supported overall patient healing outside of the OR through low inflammatory response,³ reduced risk of CSF leaks through watertight closure,^13,14 and high biocompatibility, low antigenicity and tissue integration with reliable suture retention, resistant to suture line bleeding.^4-10 The patches are recognized for providing strength, durability, and superior handling in soft tissue repair.²

Potential Advantages of Bovine Pericardium

Native collagen grafts derived from bovine pericardium, TISSUE GUARD Family of Surgical Patches offer surgeons a strong, suturable implant with excellent handling characteristics similar to autologous tissue⁴

Strength

Strong yet supple material with consistency similar to autologous tissue^2,4,10

Handling

Easy to manipulate, contour and suture to the anatomy^2,3

Biocompatible

Inert, low immunogenic properties with excellent host tissue response^2,4,7

Resistant

Reapproximates to suture, resisting leakage and minimal suture line bleeding^3,4,10,11

A Heritage of Healing

With more than 1.3 million units sold, our Tissue Guard Family of Surgical Patches offer clinical application across a broad range of indications including vascular, neurological, thoracic and cardiothoracic surgery.¹

DURA-GUARD Dural Repair Patch

For use as a dura substitute for the closure of dura during neurosurgery

APPLICABLE PROCEDURES:

Tumor Resection

Trauma

Congenital Disorders

CLINICAL BENEFITS:

Strong yet flexible material with minimal elasticity similar to native dura^12,26

Easy to manipulate, contour and suture to the anatomy³

Reduces risk of CSF leaks through watertight closure^13,14

Good for high and low pressure CSF sites^12*

_{*Preclinical data. Results may not correlate to results in humans.}

VASCU-GUARD Vascular Repair Patch

For use in peripheral vascular reconstruction, including the carotid, renal, iliac, femoral, profunda, tibial vessels and arteriovenous access revisions.

APPLICABLE PROCEDURES

Carotid endarterectomy

Profundaplasty

Femoral, Iliac, Renal, and Tibial patching

CLINICAL BENEFITS

Resists suture line bleeding^2,4

Reduced long-term restenosis rates when compared to Dacron angioplasty and primary closure¹⁵

Facilities Doppler ultrasound directly through patch¹⁵

Low incidence of post-operative and long term adverse events^{10, 15, 16, 28}

VASCU-GUARD Preparation Video

PERI-GUARD & SUPPLE PERI-GUARD Repair Patch

For use as a prosthesis for surgical repair of pericardial structures and soft tissue deficiencies which include:

defects of the abdominal and thoracic wall

hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal and umbilical)

PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.

APPLICABLE PROCEDURES:

Repair of Pericardial structures

Intracardiac & great vessel & Septal defect repair

Annulus & Soft tissue deficiency repairs

Suture-line buttressing

Thoracic & cardiothoracic surgery

CLINICAL BENEFITS:

No long-term signs of graft degeneration following aortic value reconstruction²¹

Favorable mid to long-term outcomes following aortic value reconstruction^21,22

Complete lung expansion following chest wall reconstruction²³

No signs of herniation post chest wall reconstruction²⁴

Reduced adhesions and inflammation^24,25

PERI-GUARD and SUPPLE PERI-GUARD Preparation Video

PERI-GUARD and SUPPLE PERI-GUARD have similar indications for use and applicable procedures, however, handling characteristics differ. PERI-GUARD has stiffer handling characteristics than SUPPLE PERI-GUARD due to additional stretching and dehydration steps taking during the manufacturing process. Use of a stiffer product configuration is a matter of physician preference and is not expected to have a clinical impact.

Additional TISSUE GUARD Family of Surgical Patches Benefits

Low Risk of Inflammatory Response

Through a proprietary manufacturing process, the intrinsic nature of the bovine pericardum material is maintained while meeting high levels of biocompatibility and demonstrating a low risk of inflammatory response.^2,3,17-20

Strength, Durability and Excellent Handling

The Tissue Guard family of surgical patches are similar to autologous tissue and are easy to handle and suture through; they resist suture line bleeding with excellent reapproximation^2-4,10

Multiple Size Options

The Tissue Guard family of surgical patches offer multiple size options and readily conform to multiplanar shapes.

Indications and Important Risk Information

DURA-GUARD

INDICATIONS FOR USE
DURA-GUARD Dural Repair Patch is intended for use as a dura substitute for the closure of dura mater during neurosurgery.

SELECT IMPORTANT RISK INFORMATION DURA-GUARD is not designed, sold or intended for use except as indicated.

SELECT WARNINGS Failure to rinse the product may result in a sterile inflammatory reaction. Do Not freeze. The patch must remain moist at all times.

Rx only. For safe and proper use of this device refer to the complete Instructions for Use.

VASCU-GUARD
Indications For Use
Vascu-Guard Vascular Patch is used for peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial vessels and arteriovenous revisions.

SELECT IMPORTANT RISK INFORMATION
VASCU-GUARD is not designed, sold or intended for use except as indicated.

SELECT WARNINGS Failure to rinse the product may result in a sterile inflammatory reaction. Do Not freeze. The patch must remain moist at all times.

Rx only. For safe and proper use of this device refer to the complete Instructions for Use.

PERI-GUARD

INDICATIONS FOR USE
Peri-Guard Repair Patch (PERI-GUARD) is intended for use as a prosthesis for surgical repair of pericardial structures and soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric binding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal, and umbilical hernias). Peri-Guard is also intended for use as a patch material for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.

SELECT IMPORTANT RISK INFORMATION
PERI-GUARD is not designed, sold or intended for use except as indicated.

SELECT WARNINGS Failure to rinse the product may result in a sterile inflammatory reaction. Do Not freeze. The patch must remain moist at all times.

Rx only. For safe and proper use of this device refer to the complete Instructions for Use.

SUPPLE PERI-GUARD

INDICATIONS FOR USE
SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure and soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal and umbilical).

SELECT IMPORTANT RISK INFORMATION
SUPPLE PERI-GUARD is not designed, sold or intended for use except as indicated.

SELECT WARNINGS Failure to rinse the product may result in a sterile inflammatory reaction. Do not freeze. The patch must remain moist at all times.

Rx only. For safe and proper use of this device refer to the complete Instructions for Use.

TISSUE GUARD Family of Surgical Patches Full Instructions for Use:

See References

Data on File. Baxter Healthcare Corporation, TGCS2013.
Biasi GM, Mingazzini P, Baronio L, et al. Processed bovine pericardium as patch angioplasty for carotid endarterectomy: a preliminary report. Cardiovasc Surg. 1996;4(5):848-852.
Anson JA, Marchand EP. Bovine pericardium for dural grafts: clinical results in 35 patients. Neurosurgery. 1996;39(4):764-8.
Matsagas MI, Bali C, Arnaoutoglou E, et al. Carotid endarterectomy with bovine pericardium patch angioplasty: mid-term results. Ann Vasc Surg. 2006;20:614-619.
Deeken et al. (2011)
Melman et al. (2011)
de Castro Brás et. (2011)
Papakostas et al. (2014)
Zerris, V.A., et al. (2007). Repair of the Dura Mater With Processed Collagen Devices. J Biomed Mater Res Part B: Appl Biomater, 83B: 580–588.
Biasi GM, Sternjakob S, Mingazzini PM, Ferrari S. Nine-year experience of bovine pericardium patch angioplasty during carotid endarterectomy. J Vasc Surg. 2002;36:271-277.
Kim GE, Kwon TW, Cho YP, et al. Carotid endarterectomy with bovine patch angioplasty: a preliminary report. Cardiovasc Surg 2001;9:458-462.
Zerris, Vasilios A; James, Kenneth S; Roberts, Julie B; Bell, Eugene; Heilman, Carl B Journal Title: Journal of Biomedical Materials Research Part B: Applied Biomaterials Publisher: John Wiley & Sons, Inc. 11/2007 Volume: 83 Issue: 2 Pages: 580-8.
Williams DF, Bezuidenhout D, de Villiers J, Human P, Zilla P. Long-Term Stability and Biocompatibility of Pericardial Bioprosthetic Heart Valves. Frontiers in Cardiovasc Medicine. 2021 Sep 13; Vol. 8:728577.
Khan, Shahid Ahmed; Laulloo, Asifa; Vats, Atul; Nath, Fred, Microvascular decompression: incidence and prevention of postoperative CSF leakage in a consecutive series of 134 patients, British Journal of Neurosurgery Publisher: Taylor & Francis, 8/2020 Volume: 34 Issue: 4 Pages: 416-418.
Ho, K.J., et al (2012). Intermediate-term outcome of carotid endarterectomy with bovine pericardial patch closure compared with Dacron patch and primary closure. J Vasc Surg, Mar;55(3):708-14.
Grimsley, B.R., et al. (2001). Bovine pericardial patch angioplasty in carotid endarterectomy. The American Surgeon, 67: 890-895.
VASCU-GUARD Peripheral Vascular Patch Instructions for Use. (0742171C).
DURA-GUARD Dural Repair Patch Instructions for Use. (MS-0742149A).
PERI-GUARD Pericardium Patch Instructions for Use. (0735061D).
SUPPLE PERI-GUARD Pericardium Patch Instructions for Use. (0735059E).
Weiss, S., et al. (2017). Self Made Xeno-pericardial Aortic Tubes to Treat Native and Aortic Graft Infections. Eur J Vasc Endovasc Surg. 54(5):646-652.
Song, MG YH., et al. (2014). Aortic valve reconstruction with leaflet replacement and sinotubular junction fixation: early and midterm results. Ann Thorac Surg, 97(4):1235-1241.
Redwan B., et al. (2015). A novel surgical approach for diaphragmatic plasty using biological patches in patients with idiopathic diaphragm palsy. Conference Publication: 23rd European Conference on General Thoracic Surgery 31 May–3 June 2015, Lisbon, Portugal.
Hellie, U., et al. (2013). Chest wall resection and reconstruction for locally advanced primary breast cancer. Arch Gynecol Obstet, 287:1205–1209.
Robertson, F.P., et al. (2015). A diaphragmatic retroperitoneal cyst. Ann R Coll Surg Engl, 97(5):77-78.
Kirsch WM, Zhu YH, Chrisler J, et al. Glutaraldehyde cross-linked bovine pericardium as a dural substitute: a report of clinical and experimental studies. Presented at the American Association of Neurological Surgeons, April 1996.
Williams, L.E., (2013). The need in dural graft suturing in Chiari I malformation decompression: A prospective, single blind, randomized trial comparing sutured and sutureless duraplasty materials. Surg Neurol Int, 4:26.
Dorweiler, B. et al. (2015). Long-Term Performance of the Bovine Pericardium Patch in Conventional Carotid Endarterectomy. Thorac Cardiovasc Surg, Mar;63(2):168-74.

35+ YEARS OF CLINICAL HISTORY

Native collagen grafts derived from bovine pericardium, TISSUE GUARD Family of Surgical Patches offer surgeons a strong, suturable implant with excellent handling characteristics similar to autologous tissue4

Strength

Handling

Biocompatible

Resistant

A Heritage of Healing

DURA-GUARD Dural Repair Patch

For use as a dura substitute for the closure of dura during neurosurgery

APPLICABLE PROCEDURES:

Tumor Resection

Trauma

Congenital Disorders

CLINICAL BENEFITS:

Strong yet flexible material with minimal elasticity similar to native dura12,26

Easy to manipulate, contour and suture to the anatomy3

Reduces risk of CSF leaks through watertight closure13,14

Good for high and low pressure CSF sites12*

VASCU-GUARD Vascular Repair Patch

For use in peripheral vascular reconstruction, including the carotid, renal, iliac, femoral, profunda, tibial vessels and arteriovenous access revisions.

APPLICABLE PROCEDURES

Carotid endarterectomy

Profundaplasty

Femoral, Iliac, Renal, and Tibial patching

CLINICAL BENEFITS

Resists suture line bleeding2,4

Reduced long-term restenosis rates when compared to Dacron angioplasty and primary closure15

Facilities Doppler ultrasound directly through patch15

Low incidence of post-operative and long term adverse events10, 15, 16, 28

PERI-GUARD & SUPPLE PERI-GUARD Repair Patch

For use as a prosthesis for surgical repair of pericardial structures and soft tissue deficiencies which include:

defects of the abdominal and thoracic wall

hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal and umbilical)

PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.

APPLICABLE PROCEDURES:

Repair of Pericardial structures

Intracardiac & great vessel & Septal defect repair

Annulus & Soft tissue deficiency repairs

Suture-line buttressing

Thoracic & cardiothoracic surgery

CLINICAL BENEFITS:

No long-term signs of graft degeneration following aortic value reconstruction21

Favorable mid to long-term outcomes following aortic value reconstruction21,22

Complete lung expansion following chest wall reconstruction23

No signs of herniation post chest wall reconstruction24

Reduced adhesions and inflammation24,25

Additional TISSUE GUARD Family of Surgical Patches Benefits

Low Risk of Inflammatory Response

Strength, Durability and Excellent Handling

Multiple Size Options

Are you interested in additional information about our tissue technologies?

Indications and Important Risk Information

Native collagen grafts derived from bovine pericardium, TISSUE GUARD Family of Surgical Patches offer surgeons a strong, suturable implant with excellent handling characteristics similar to autologous tissue⁴

Strong yet flexible material with minimal elasticity similar to native dura^12,26

Easy to manipulate, contour and suture to the anatomy³

Reduces risk of CSF leaks through watertight closure^13,14

Good for high and low pressure CSF sites^12*

Resists suture line bleeding^2,4

Reduced long-term restenosis rates when compared to Dacron angioplasty and primary closure¹⁵

Facilities Doppler ultrasound directly through patch¹⁵

Low incidence of post-operative and long term adverse events^{10, 15, 16, 28}

No long-term signs of graft degeneration following aortic value reconstruction²¹

Favorable mid to long-term outcomes following aortic value reconstruction^21,22

Complete lung expansion following chest wall reconstruction²³

No signs of herniation post chest wall reconstruction²⁴

Reduced adhesions and inflammation^24,25