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DERMABOND™ PRINEO™ System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND™ PRINEO™ System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octylcyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND™ PRINEO™ System acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties. DERMABOND™ PRINEOTM System also incorporates 2 self-adhering meshes that are applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 40 cm in length until the liquid adhesive is applied to achieve skin closure.

The PROXISURE™ Suturing Device, ETHIBOND™ Suture Cartridge, and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue. The PROXISURE™ Suturing Device and ETHIBOND™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue. The PROXISURE™ Suturing Device and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

The PROXISURE™ Suturing System is composed of a reusable PROXISURE™ Suturing Device and single-use, sterile Suture Cartridges that are used for placement of interrupted or running stitches in soft tissue. The Suturing Device has a stationary shaft that has an articulating and rotating end effector. The device is reusable and must be cleaned and sterilized by the end user per the cleaning, disinfection, and sterilization instructions provided in the Instructions for Use before and between uses. A Suture Cartridge is loaded at the distal tip of the end effector which contains the needle and suture for use during the surgical procedures. The PROXISURE ™ Suture Cartridges are designed for use with the PROXISURE™ Suturing Device and are available with two types of sutures in three sizes each. The suture material is commercially available Coated VICRYL™ and ETHIBOND EXCEL™ sutures. ETHIBOND™ Suture is dyed green with D&C Green #6 (Color Index No. 61565) to enhance visibility in the surgical field. ETHIBOND Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) for sterile poly(ethylene terephthalate) Suture and the United States Pharmacopoeia (USP) for Non-Absorbable Surgical Sutures. Coated VICRYL™ Sutures that come with the Suture Cartridge are dyed by adding D+C violet #2 (Color Index number: 60725) during polymerization. Coated VICRYL™ Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP) for Sterile Synthetic Absorbable Braided Sutures, except for an occasional slight oversize in the gauges for the suture cartridge. The PROXISURE™ Suturing Device and the Suture Cartridges are packaged separately and will be available for assembly prior to use at the surgical site.