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The Mi-CHORD System is indicated for the replacement of adult mitral chordae tendineae with the patient on cardiopulmonary bypass, with the heart either arrested or fibrillating, and the surgical field under direct visualization. Direct visualization, in this context, requires that the surgeon is able to see the heart and target tissues in a bloodless field, with or without assistance from an operating telescope or videoscopy.

The Mi-CHORD™ System, shown in Figure 1, is a sterile, single use system, including the Mi-STITCH™ suturing device with its loaded LS-5™ expanded polytetrafluoro-ethylene (ePTFE) suture (Figure 2) and the Mi-KNOT™ device with its loaded Mi-KNOT™ titanium fastener (Figure 3).

The MD™ MATTRESS Suture Placement Device is indicated for use in the approximation of soft tissue and prosthetic materials.

The MD™ MATTRESS Device is a nonpowered, hand-operated suture placement device that facilitates placement of a stitch, for example horizontal mattress stitches. Each sterile package contains one single-patient-use MD™ MATTRESS Device. The lavender device tip has an integrated tissue jaw incorporating a jaw width indicator that identifies the jaw when it is embedded in tissue. Two curved needles emerge from their protective compartments to advance across the tissue jaw, rotating about the circular needle axle indicator to engage needle caps with attached suture that are loaded into specialized needle cap compartments. An angulation indicator on the tip and the device shaft depicts the direction of the device tip angle, which is adjusted using the white angulation knob. The embossed arrow and word "IN" indicate the direction the device tip moves when the angulation knob is rotated clockwise; the device tip can be angled up to approximately 15° in either direction, as indicated by the 3 embossed radial lines in the angulation indicator The lavender rotational knob can be rotated to orient the device shaft and tip into one of six distinct positions. The rotational knob has an integrated eyelet, for stabilizing a suture tube with indwelling suture, and an indicator fin that is aligned with the device tip tissue jaw. Fully squeezing the lavender lever toward the white handle causes both curved needles in the device tip to advance across the tissue jaw toward the needle cap compartments. Fully releasing the lever causes both needles and their engaged needle caps with attached suture to retract back across the tissue gap, pulling both suture ends through the targeted tissue within the jaw. Fully squeezing the lever again causes the needles and engaged needle caps with attached suture to advance back into their corresponding needle cap compartments, and an internal mechanism alternates the device into its rearming mode. Fully releasing the lever again causes the needles to retract into their protective compartments, leaving the needle caps and attached suture ends in the needle cap compartments. Subsequently squeezing and releasing the lever will repeat the pickup and rearm cycle.

The COR-KNOT MICRO™ device with COR-KNOT MICRO™ fastener when used in conjunction with USP 6-0, 7-0, or 8-0 polypropylene surgical suture, is indicated for use in the approximation of soft tissue.

The COR-KNOT MICRO™ Device is a sterile, single patient use device provided to the user preloaded with a single COR-KNOT MICRO™ fastener. Made from medical grade titanium, the COR-KNOT MICRO™ fastener is a hollow sleeve with a rounded base. A white plastic target holds the loop shape of a wire snare. The wire snare passes through the COR-KNOT MICRO™ fastener and is attached to a snare puller knob. A suture slot in the device shaft lies under the opening in the snare puller. The ends of a USP 6-0, 7-0, or 8-0 polypropylene suture are passed through the wire snare and subsequently threaded into the titanium fastener. The snare puller attached to its wire snare is pulled up along the device shaft until it snaps onto the puller retainer feature of the purple knob, which also has an integrated indicator fin. The suture slot and the indicator fin are located on the same side of the device shaft. The subsequently crimped fastener and remnant trimmed suture tails bend slightly in the direction away from or opposite from the suture slot and indicator fin. By rotating the purple knob and the device's white handle, the surgeon can ergonomically orient the direction of the suture tails, if desired. A yellow lever stop is located behind the purple lever to restrict inadvertent squeezing of the lever during device handling before crimping. The lever stop is removed by pinching its sides together and pulling it out of the handle. By squeezing the purple lever, the COR-KNOT MICRO™ Device crimps the COR-KNOT MICRO™ fastener to fasten together segments of suture and trims away excess suture. One COR-KNOT MICRO™ Device is provided per package, and the COR-KNOT MICRO™ Device is not intended to be reloaded or reused. The COR-KNOT MICRO™ device is intended for use in the approximation of soft tissue.

The RD® QUICK LOAD® suture is intended for use in general soft tissue approximation and/or ligation.

LSI SOLUTIONS® RD® QUICK LOAD® SUTURE is a non-absorbable surgical suture available as monofilament polypropylene suture (diameter of USP size 2-0) and polytetrafluoroethylene (PTFE)-coated, braided polyester suture (diameter of USP sizes 0 and 2-0). A short length of surgical stainless-steel tubing, called a "needle cap," is attached to one end of the suture. The needle cap is removed from the suture after suturing is completed and not meant for implantation into the patient. The RD® QUICK LOAD® SUTURE includes a detachable clear suture tube to keep the suture from tangling. The RD® QUICK LOAD® SUTURE is packaged for single patient use and is provided sterile by means of a validated ethylene oxide (EO) cycle. The polypropylene suture is dyed blue with the FDA approved colorant [phthalocyaninato(2-)] copper and will be offered with a surgical suture diameter of USP size 2-0 and in a length of 53 inches. The polyester suture is offered dyed green with the FDA approved colorant D&C Green No. 6 and is offered in a surgical suture diameter of USP size of 0 and 2-0 and a length of 53 inches. For both polypropylene and polyester suture, there is no known significant change in tensile strength retention to occur in vivo. The RD® QUICK LOAD® SUTURE products, with needle caps removed, contain implantable components which are considered MR (magnetic resonance) safe. The implantable polyester and polypropylene suture materials are non-metallic and nonconducting materials and therefore, considered MR safe.

The LSI Solutions® ForniSee™ is intended for use as a uterine manipulator in laparoscopic hysterectomy surgical procedures to identify the vaginal fornices and manipulate the uterus.

LSI SOLUTIONS® ForniSee™ System will provide aid in the tissue manipulation typically encountered in patients requiring a hysterectomy. The ForniSee™ System provides single-patient use FS Devices and its companion reusable FS Sounds; these components are made from common surgical metals and polymers. Sterile disposable, mostly plastic, FS Device surgical hand tools will be offered in three different sizes designated as either FS-30, FS-35 or FS-40, with the number indicating the increasing diameter of the inside of the device's distal cervical cups. The FS Device is designed with an optional integrated vaginal illumination component. FS Sounds are reusable implements, which are essentially customized angled shafts or sounds constructed of cleanable and resterilizable surgical quality metal; the distal ends of these FS Sounds will be offered in four different sizes ranging in length from 6 to 8 to 10 to 12cm. FS Devices fit over FS Sounds to provide an effective means of uterine manipulation during laparoscopic surgery. FS Devices and FS Sounds will be manufactured at our facility in Victor, New York.

Approximation of soft tissue and prosthetic materials

LSI SOLUTIONS® Suture Placement Devices, Accessories and Quick Load® products, specifically the RD-180 suturing device and its 2-0 non- absorbable polyester and polypropylene suture load units along with the TK Ti-Knot® knot replacement device and its Titanium Knot® loads, will effectively approximate tissue and prosthetic material.