Bioresorbable Protective Sheet

CardioWrap® Bioresorbable Protective Sheet offers an innovative option for postsurgical healing following interventional cardiothoracic surgery. CardioWrap® is a protective sheet made from an amorphous bioresorbable copolymer 70:30 Poly(L-lactide-co-D,L-lactide) commonly referred to as PLA. Place the CardioWrap® Bioresorbable Protective Sheet over a pericardial defect for use as a pericardical repair device in patients that require reoperation in 6 months. The demonstrated safety record combined with excellent handling characteristics makes CardioWrap® an excellent choice for cardiothoracic procedures.

Safety

PLA has no known side effects with minimal risk of inflammatory reaction. (1,2,3) PLA and similar resorabable materials have been used in surgical implants and suture materials for over thirty years.(1,3)

Transparent

Virtually weightless protective sheet is clear and allows for complete visualization of anatomy for ease of placement.

Handling Characteristics

CardioWrap® is easily repositioned in wet environments, can be sutured into place for complete surgeon control, and can easily be trimmed and cut for specific anatomical considerations.

Impermeable

Independent laboratory testing has determined that CardioWrap® is impermeable throughout the critical healing period and up to 8 weeks.

Biocompatible

The bioresorbable protective sheet is a synthetic match to the natural lactic acid molecule, is inert, and is naturally absorbed through bulk hydrolysis. (1,3)

Strength

CardioWrap® comes in two thicknesses, 0.02mm and 0.05mm, and retains significant tensile strength (greater than 80% and 100% respectively) for the initial 8 weeks and decreases in a controlled fashion through 24 weeks.

Literature

CardioWrap® Bioresorbable Protective Sheet Product Brochure
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Application of CardioWrap® Bioresorbable Sheet in Cardiothoracic Procedures
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References

1. Holmes, R.E., Cohen, S.R., Cornwall, G.B., Thomas, K.A., Kleinhenz, K.K. and Beckett, M.Z. “MacroPore Resorbable Devices in Craniofacial Surgery.” Clin Plast Surg. 31(3):33-406, 2004.

2. Tai, J.W., Wiseman, D.M., Moser, R.C. and Thomas, K.A. “Resorbable Polylactide Film Does Not Inhibit Healing in a Rabbit Anastomosis Model.” Society for Biomaterials 30th Annual Meeting, 316.

3. Middleton, J.C. and Tripton, A.J. “Synthetic Biodegradable Polymers as Orthopedic Devices.” Biomaterials. 21:2335-2346, 2000.

4. Klopp, L.S., Welch, W.C., Tai, J.W., Bioeng, M., Toth, J.M., Cornwall, G.B. and Turner, A.S. “Use of Polylactide Resorbable Film as a Barrier to Postoperative Peridural Adhesion in an Ovine Dorsal Laminectomy Model.” Neurosurgical Focus. 16(3) Article 2, 2004.

5. Rossi, C., Margaritondo, E., Bizzari, F. and Costanzo, G. “La Barriera Antiderenziale MacroPore’s SurgyWrap Nel Trattamento Chirurgico Delle Sindromi da Compressione Nervosa Dell’arto Superiore.” Riv Chir Mano. 41(3):158-162, 2004.

6. Walsh, W.R., Evans, R.N., Iliopoulos, J., Cornwall, G.B. and Thomas, K.A. “Evaluation of a Bioresorbable Polylactide Sheet for the Reduction of Pelvic Soft Tissue Attachments in a Porcine Animal Mode.” J Biomed Mater Res Part B: Appl Biomater. 79B:166-175, 2006.

7. Iliopoulos, J., Cornwall, G.B., Evans, R.N., Manganas, C., Thomas, K.A., Newmanm, D.C. and Walsh, W.R. “Evaluation of a Bioresorbable Polylactide Film in a Large Animal Model for the Reduction of Retrosternal Adhesions.” J Surg Res. 118: 144-153, 2004.

8. Williams, N. “Management of Tissue Attachmens Through the Use of SurgiWrap Bioresorbable Sheets.” Clin Insights Bariatric Surg. 1(1): Jan/Feb, 2005.

9. Cornwall, G.B., Walsh, W.R., Iliopoulos, J., Thomas, K.A., Dona, E., Kleinhenz, K., Manganas, C. and Newman, D. “Long Term Evaluation of a Polylactide Film in a Retrosternal Pericardial Adhesion Model.” Transactions of the Seventh World Biomaterials Congress; Sydney, Australia, P. 1050, May, 2004.

10. Lee, C. and Alexander, H. “Prevention of Postlaminectomy Scar Formation.” Spine. 9:305-312, 1984.

11. Medinaceli, L., Khoury, R. and Merle, “Large Amounts of Polylactic Acid in Contact with Divided Nerve Sheaths Have No Adverse Effects on Regeneration.” J Recon Microsurg.11:43-49, 1995.

12. Rodgers, K., Cohn, D., Hotovely, A., Pines, E., Diamond, M. and diZerega, G. “Evaluation of Polyethylene Glycol/Polylactic Acid Films in the Prevention of Adhesions in the Rabbit Adhesion Formation and Reformation Sidewall Models.” Fertility and Sterility. 69: 403-408, 1998.

13. Yamaoka, t., Takahashi, Y., Fujisato, T., Lee, C., Tsuji, T., Ohta, T., Murakami, A. and Kimura, Y. “Novel Adhesion Prevention Membrane Based on a Bioresorbable Co Poly (Ester-Etehre) Comprised of Poly-LLactide and Pluronic: In Vitro and In Vivo Evaluations.” J Biomed Mater Res. 54:470-479, 2001.

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