The Science Behind Sylys® Surgical Sealant

cohera_medical_laboratorySylys® Surgical Sealant may be an effective adjunct to reduce anastomosis leaks after gastrointestinal procedures. Sylys Surgical Sealant also has the potential to reduce leaks following dural and lung surgical procedures.

Sylys® Surgical Sealant is a new, highly-elastic, resorbable synthetic surgical sealant designed to help reduce anastomotic leakage in gastrointestinal procedures by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur.

Single Component

Sylys is the first medical sealant to utilize unique chemistry to produce a rapid curing, single-part sealant with good adherence to tissue. The curing process is initiated by contact with the moisture in the tissue, so no mixing or complicated preparation is required.

Resorbable

The cured sealant forms a network of large polymeric chains that allows the sealant to remain soft and flexible while also creating a strong tissue bond. The sealant remains well adhered to the tissue during the first two weeks after surgery, and then proceeds to break down into harmless subcomponents over a period of 3 months.

No mixing

Sylys Surgical Sealant is a single-part synthetic sealant that requires no mixing. The sealant is delivered easily and evenly through a custom design applicator that aids the surgeon in applying the sealant either in open or laparoscopic surgical procedures.

High Strength

By forming a strong, elastic barrier over the standard anastomotic closure, Sylys supports the suture or staple line during healing to help prevent the occurrence of leaks. Burst strength testing of the product shows that it is able to withstand pressures over 150 mmHg, twice that of normal bowel peristalsis.

Sylys® Surgical Sealant Preclinical Efficacy

A preclinical mouse anastomosis study was conducted to demonstrate efficacy of Sylys Surgical Sealant at preventing anastomotic leaks. Three groups were tested:

Sylys_science Control group (complete repair)
 Leak group (incomplete repair)
 Leak + Sylys Surgical Sealant group (incomplete repair treated with Sylys)

The results of the study showed that Sylys Surgical Sealant (Leak + Sylys group) produced a 58% reduction in mortality rate and a 65% reduction in leak rate in comparison to the Leak group that received no sealant.

A recent publication1 using a nearly identical mouse anastomosis model evaluated the performance of six commercially available sealants. The study showed that none of the tested sealants improved the rate of anastomotic leaks when compared to the control animals with no sealant, and most sealants worsened morbidity and mortality.  The positive outcomes obtained with Sylys are dramatic when compared to the failure of the currently available sealants in the bowel application, and reinforce the unique value Sylys brings to this unmet clinical need.

Clinical Studies

A first-in-human safety trial was completed in Europe in 20142.  The objectives of this clinical evaluation were to determine safety of the Sylys Surgical Sealant used during open ileostomy reversal procedures and to examine performance of its delivery method. Based on the results of this clinical investigation, it was shown that Sylys Surgical Sealant is a safe adjunct to standard closure techniques during an ileostomy reversal procedure.

These results support the conduct of future clinical investigations to study the efficacy of Sylys Surgical Sealant in reducing anastomotic leakage in patients undergoing colorectal surgery.

References:

1. Slieker, J.C., et al., Prevention of leakage by sealing colon anastomosis: experimental study in a mouse model. J Surg Res, 2013. 184(2): p. 819-24.

2. Stam, M.A., et al., Sylys surgical sealant: a safe adjunct to standard bowel anastamosis closure.Annals of Surgical Innovation and Research, 2014. 8(6): p. 4.

Sylys Surgical Sealant is not currently available for sale or distribution and has not been approved by the U.S. FDA or any other country’s regulatory authority. The device described is currently limited to investigational use only in the E.U.

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