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The Modified Omniwave Endovascular System is indicated for use in the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature and for removal of thrombi from the peripheral vasculature.

The Modified Omniwave Endovascular System is comprised of two major components: (1) the sterile, single use Kit, and (2) the multi-use Generator.

The Omniwave Endovascular System is indicated for use in the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature and for removal of thrombi from the peripheral vasculature.

The Omniwave Endovascular System is comprised of two major components: (1) the sterile, single use Kit, and (2) the multi-use Generator.

The Omnisonics Resolution® Endovascular System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.

The Resolution Endovascular System is a portable ultrasound energy system for the treatment of thrombosed synthetic dialysis access grafts. The System is comprised of two major components: (1) the sterile, single use Resolution Therapeutic Kit, and (2) the multi-use Generator. Required accessories include the Resolution Delivery Catheter and a commercially available hemostasis valve.

The Omnisonics Resolution® Thrombectomy System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.

The Resolution Thrombectomy System is a portable acoustic energy system for the treatment of thrombosed synthetic dialysis access grafts. The system is comprised of three major components: (1) the disposable Resolution 360° Therapeutic Wire, (2) the reusable Handpiece/Cable Assembly, and (3) the multiuse Generator. Accessories include the Resolution Torque Wrench and Resolution Irrigation Tubing Set.

The intended use of the OmniSonics Ultrasonic Probes is the breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic. The OmniSonics Ultrasonic Probes are used in conjunction with the OmniSonics Ultrasonic Surgical System. The OmniSonics Ultrasonic Probes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the probe.

The OmniSonics Ultrasonic probes work in conjunction with the OmniSonics Ultrasonic Generator. The generator creates a specific electrical signal that is directed into the OmniSoncs ultrasonic handle. The signal is converted into an ultrasonic motion within the handle and this motion is transferred to the ultrasonic probe. The ultrasonic energy in contact with the probe causes a specifically defined motion to occur on the probe shaft. The motion of the probe in contact with the tissue causes a localized cavitation, and immediate destruction of the tissue in contact with the probe. Cavitation is caused by the motion of the probe within water and in contact with tissue. The motion of the probe causes the formation of microbubbles to be formed. The upstoke of the probe causes the formation of the bubble behind the probe, the downstroke causes the collapse of the bubble and a small localized shock wave. This focused wave formed at the tip of the probe causes a localized and focused shock wave to be formed which impinges upon the tissue and breaks off the most least tightly bound tissue layer. The action is limited to a specific contact area of the probe upon the tissue, and does not travel beyond these contact points. The OmniSonics Ultrasonic Probes are constructed of titanium and are all specifically designed for use and operation with the OmniSonics Ultrasonic Surgical System. The specifications of the proposed OmniSonics Ultrasonic Probes are the following: Diameter Exterior: 1 mm - 10 mm Diameter Interior: .5 mm - 8 mm Length: 10 mm - 30 mm

The OmniSonics Endoscopic Deflector is designed to assist in the placement and deflection of I he Onlinoomiss indoscopic Donector atheters and endoscopes used in surgical procedures in body cavities, hollow organs and canals. The OmniSonics Endoscopic Deflector is designed to be introduced through natural body openings, surgical incisions and through introducers, needles, trocars, catheters, sheaths and other devices with lumens having an inside diameter larger than the outside diameter of the OmniSonics Endoscopic Deflector shaft selected. The OmniSonics Endoscopic Deflector is sold sterile and is intended for single patient use. The OmniSonics Endoscopic Deflector is indicated for the following applications: Ureteroscopy Thoracoscopy Nasopharyngoscopy Sinuscopy General laparoscopy Urology Gynecology Bronchoscopy

The OmniSonics Endoscopic Deflector assists in the delivery of small diameter flexible; instruments, catheters, probes, and endoscopes. The device deflects these instruments to aid in the direction and delivery of the product to a specific surgical site that is not in line with the axis of the instrument. The purpose of the OmniSonics Endoscopic Deflector is to provide a means to deliver small diameter instruments to areas that would be difficult to access with a straight instrument. The OmniSonics Endoscopic Deflector works in a similar fashion to steerable endoscopes. This instrument is different in that it only contains lumens for the introduction of ancillary instrumentation and does not possess an integral visualization system. The user must insert all of the additional capabilities desired through the OmniSonics Endoscopic Deflector central lumen. Products that are capable of working with the OmniSonics Endoscopic Deflector are flexible, malleable or bendable and must be capable of obtaining a bend radius of 30 mm or less. They must also have an outer diameter compatible with the inner diameter of the unit selected. The actual deflection produced at the end of the device will depend upon the stiffiess of the inserted instrument. The OmniSonics Deflector is constructed with the following major components: Outer sheath tube: A rigid, stainless steel tube that provides rigidity for insertion into the body Deflection tube: A flexible, polyurethane, kink resistant tube that bends when the deflection handle is activated. Deflection wire: A stainless steel wire that pulls the tip of the deflection tube to cause deflection. Deflection handle: An ABS handle that has mechanisms for rotation of the shaft, articulation of the deflection tube, movement of the inserted device in and out and sealing of the inserted device.

The OmniSonics Endoscopes are intended for visualization of body cavities, hollow organs, and canals. The OmniSonics Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The OmniSonics Endoscopes are indicated for the following applications: Ureteroscopy, Bronshoscopy, Thoracoscopy, Nasopharyngoscopy, Sinuscopy, General laparoscopy, Urology, Gynecological.

The OmniSonics Endoscopes are fiber optic designed endoscopes offered in a variety of lengths, diameters and configurations for user convenience. The fiberoptic endoscope functions by light being transmitted from a standard external high intensity light source through illumination fibers to the distal tip of the scope. The image is transmitted via a fiber-imaging bundle to an eyepiece. The image is viewed directly or transmitted through a video camera to a monitor. The device is provided with a reusable coupler and is also compatible with other standard couplers currently marketed.