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The Evolution of Bioresorbable Sheet
Before the advent of bioresorbable materials, the closure of soft tissue was limited to permanent materials such as nylon sutures. Advances in material sciences led to the development of bioresorbable polymer sutures that met the clinical needs of holding soft tissues together, while serving the patient's need of not remaining permanently in the body.
The evolution of bioresorbable polymer technology facilitated the development of large bioresorbable polymer sheets that could span large tissue masses and subsequently hold them in place. The thin sheets facilitate the healing of larger tissue masses and virtually eliminating many adverse effects of permanent implants.
Bioresorbable Material
Bioresorbable surgical thin sheet for soft tissue applications, made from polylactide (PLA): a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). Composed of lactic acid similar to that which occurs naturally in the human body, the copolymer maintains its strength during the healing process, and through hydrolysis slowly breaks down into lactic acid molecules. The molecules are ultimately metabolized into carbon dioxide and water and are released from the body through the lungs.
Bioresorbable Sheet Advantages
- Transparent, ultra thin profile to allow simplified intraoperative placement and repositioning without obscuring visualization of underlying tissues.
- Significant strength retention for up to 8 weeks to maintain support throughout critical healing period.
- Bioresorbable/biocompatible material provides safe resorption and metabolization with minimal risk of inflammatory reaction.
- No human or animal components, avoids the risk of disease transmission.
SurgiWrap® US Regulatory Clearance
- In October 2001, SurgiWrap received its first regulatory clearance from the FDA as a reconstruction sheet for the prevention of postsurgical adhesions in specific ENT (ear, nose and throat) procedures.
- In December 2001, SurgiWrap received FDA clearance for soft tissue support and for the repair of fascial defects including vaginal prolapse repair, colon and rectal prolapse repair, and reconstruction of the pelvic floor.
- In February 2003, SurgiWrap received FDA clearance to wrap orbital implants and to protect the surrounding orbital tissue.
- In September 2003, SurgiWrap received FDA clearance for use wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other facial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable protective sheet minimizes tissue attachment to the device in case of direct contact with the viscera.
- In September 2003, CardioWrap received FDA clearance for us as a pericardial replacement device in patients that may require re-operation within 6 months.
- In May 2005, SurgiWrap received FDA clearance for additional indications to include: urological, gynocological, and gastroenterological anatomy; pubourethral support, bladder support, urethral prolapse, along with indications for open and laparoscopic procedures.
- In September 2006, SurgiWrap received FDA clearance for use in the management and protection of tendon injuries and for the minimization of soft tissue attachments to the device in open and endoscopic/laparoscopic procedures.
- In March 2007, SurgiWrap received FDA clearance for reinforcement of soft tissues repaired by suture or anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons, but is not intended to provide full mechanical strength.
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