The revolutionary INSORB® Subcuticular Skin Stapler

Articles: Wall Street Journal Award Wound Infection Study  General Surgery   Plastics Surgery   Vascular Surgery

Effective and cosmetic Subcuticular interrupted closure delivers eversion with minimal tension on the wound edges Absorbable tissue-friendly copolymer No insult to epidermis Saves time and costs Rapid, easy to use…reduces OR and anesthesia time Eliminates cost and hassle associated with metal staple removal No needlesticks Demonstrated to lower infection rates in contaminated wounds and inflammation1 Greater patient satisfaction More comfortable and convenient than metal staples No painful staple removal…eliminates patient anxiety Improved cosmetic result to metal staples The absorbable new standard for skin closure The revolutionary INSORB® Subcuticular Skin Stapler is designed tocombine the cosmetic result of absorbable sutures with the rapid closure times associated with metal skin staplers, while eliminating the need for metal staple removal post-operatively. The patented INSORB|20 Subcuticular Skin Stapler is a sterile, single patient use device that deploys up to 20 staples, sufficient to close up to a 17cm incision.

Introducing the SurgiWrap

Bioresorbable Sheet

Articles: Prevention of Soft Tissue Attachment INTERCEED NEWSFLASH The Norway Abstract

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 sheets, for soft tissue applications, are 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.

Thin sheet US Regulatory Clearances

• In November 2001, the bioresorbable sheet 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, bioresorbable sheet 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 November of 2003, bioresorbable sheets 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 May of 2004, MAST Biosurgery, Inc., purchased all rights for the manufacturing, process, and sale of these bioresorbable sheets.

• In May 0f 2005, bioresorbable sheets 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

Introducing the G•Spec^TM

The most innovative weighted vaginal speculum design in over 100 years! The G•Spec™ Weighted Vaginal Speculum (WVS) is the first and only articulated WVS. It easily adjusts to any of three angles and three lengths, delivering a total of 9 optional variations with one instrument. The G•Spec™ WVS uses convenient disposable plastic blades (spoons) in 8, 10 and 12 cm lengths. The spoons are ribbed to control slippage and insure retention and are non-conductive. The ergonomic design of the 2lb. handle makes the G•Spec™ more comfortable and easier to use than the standard WVS. Made of Surgical Stainless Steel, the handle is reusable and autoclaveable. The G•Spec™'s single handle approach reduces the need for multiple WVS' on the OR tray and subsequent resterilization processing. The time saving G•Spec™ design accomodates the patient/surgeon by minimizing Trendelenburg, optimizing surgical efficiency, and providing immediate situational options as required. The traditional antiquated WVS does not possess these attributes.