Search Results

The Soprano™ Cryo-Therapy System is intended for use in the surgical ablation of tissue by the application of extreme cold in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology.

The FemRx Soprano Cryo-Therapy System is designed to be a general use cryotherapy system for the destruction or cryoablation of tissue. The system allows the circulation of a cryorefrigerant from the console to the reusable cryoprobe.

The FemRx™ Focused Monopolar (FMP) offersTAR™ System is intended for gynecologic hysteroscopic / electro-surgical use by trained professional gynecologists in hospital or office environments. It is used to resect and / or ablate endometrial tissue. INDICATIONS: Abnormal Uterine Bleeding, Submucous Fibroids, Endometrial Polyps

The FemRx Focused Monopolar (FMP) @ERASTAR™ System [with Dispersive Electrode Option] is identical to FemRx's currently cleared FMP offRASTAR™ System with the exception that it includes the option of using a standard dispersive skin electrode. When used in this way it is basically identical to our original oreRASTAR™ System except that it incorporates a PEARL electrode (Physiologic endometrial ablation / resection loop). This loop is partially insulated to "focus" the current toward the tissue and avoid the reduction in effect associated with conventional devices. The use of isotonic solutions (e.g., NaCl or Ringers Lactate) is strongly recommended in order to reduce the risks associated with fluid overload. The FMP offers TAR System differs from currently marketed bi-polar devices in that it continues to have a single active electrode (wire loop or Star loop) as opposed to two active electrodes. The return electrode (the metallic outer Morcellator housing of the device OR a standard dispersive pad located on the patients skin) has such a large surface area relative to the active electrode that there can be no tissue coagulating (much less cutting or ablating) effect at its surface.

Not Found

The FemRx Focused Monopolar (FMP) 07584STAR™ System is identical to FemRx's currently marketed of ERASTARTM System resectoscope in terms of outward appearance and basic tissue cutting, ablating and morcellating mechanism (electrocautery wire / Star loop and morcellator internal to the fluid return path). That is, high frequency current is applied to a single active electrode to either cut or coagulate tissue which is subsequently chopped up and aspirated via a morcellator internal to the fluid return path. The FMP offers TAR System differs from our previously cleared device in that the return electrode has been moved from outside of the patient body (dispersive electrode pad attached to the patients back or leg) to the metallic body of the device (outer tube/housing the morcellator). (Reference the Device Description section of this submission for an "insulation diagram" and schematic drawing providing a diagrammatic representation of the electrical circuit effect of moving the return electrode.) This change in return electrode location makes it possible to use (indeed requires the use of) a conductive irrigant solution such as normal saline (0.9% NaCl). The use of an isotonic solution eliminates significant potential complications associated with non-isotonic solutions (e.g., Mannitol, Sorbitol, Glycine). The FMP offers TAR System differs from currently marketed bi-polar devices in that it continues to have a single active electrode (wire loop or Star loop) as opposed to two active electrodes. The return electrode (the metallic outer Morcellator housing of the device) has such a large surface area relative to the active electrode that there can be no tissue coagulating (much less cutting or ablating) effect at its surface. Current densities near the surface of the morcellator housing have been measured to verify this physical impossibility.

The FemRx TURPSR™ System is intended for urological transurethral resection by trained professional urologists in hospital environments. This device is intended for resection of tissue in the urethra, prostate and bladder.

The FemRx 100°SR™ System is a refined urologic resectoscope. A standard telescope is inserted into the device and coupled to an operative video camera system prior to use. The device is compatible with a variety of standard electro-surgery units (ESUs). The system is designed to cut and coagulate prostate tissue by sliding the loop assembly in an axial manner relative to the handle/spring housing. Cutting and coagulation are accomplished by energizing the electrode with electrocautery current from an approved ESU. All cutting/coagulating occurs under visual control by a surgeon observing a video monitor displaying the view through the telescope. Cutting/coagulating is only performed while the device is moving towards the operator. Typically, the surgeon squeezes the finger rings to move cutting end distally; electrocautery is then applied and cutting/coagulating is accomplished by the active end as the spring returns the device to the most proximal resting location. The surgeon uses hand pressure to control the rate of sliding of the active end within the sheath. Separate channels are provided for irrigant inflow and outflow, permitting continuous fluid circulation for good visibility.

Not Found

The FemRx™ Morcellator System is virtually identical to the currently marketed Karl Storz STEINER™ Morcellator in terms of its tissue cutting and extraction mechanism. Both devices utilize a separate motor drive box and flexible drive a rotating cutting blade, internal to a cylindrical housing, used to cut or core tissue as it is drawn up through the central lumen of the device by the use of standard forceps. The principle difference between the FemRx™ Morcellator and the Storz device is that the FemRx device incorporates a fixed cylinder inside the rotating cutter (see figure below). The fixed (non rotating) cylinder located on the inside of the cutter is designed to reduce the torsional or rotational force applied to the cored tissue fragments as they are pulled up through the central lumen of the FemRx™ device. The FemRx™ Morcellator System also differs from the Storz device in that it is disposable and utilizes the Motor Drive Unit (MDU) that has been previously cleared as part of the FemRx™ ores STARTM and TORSTAR™ Hysteroscopic and Urological Resectosocipic Systems [510(k) numbers K954648 and K962506]. All tissue contacting materials are standard medical grade and non-toxic.

The FemRx "00"STARTM System is intended for urological transurethral resection by trained professional urologists in hospital environments. This device is intended for resection, morcellation and aspiration of tissue in the urethra, prostate and bladder.

The FemRx 700 STARTM System is a refined urologic resectoscope. The device consists of: 1) an electrode/tissue morcellator assembly including drive cable, 2) a sheath and; 3) a motor drive unit. A standard telescope is inserted into the device and coupled to an operative video camera system prior to use. The device is compatible with a variety of standard electro-surgery units (ESUs). The system is designed to cut and coagulate prostate tissue by sliding the loop/morcellator assembly in an axial manner relative to the handle/spring housing. Cutting and coagulation are accomplished by energizing the electrode with electrocautery current from an approved ESU. All cutting/coagulating occurs under visual control by a surgeon observing a video monitor displaying the view through the telescope. Cutting/coagulating is only performed while the device is moving towards the operator. Typically, the surgeon squeezes the finger rings to move cutting end distally; electrocautery is then applied and cutting/coagulating is accomplished by the active end as the spring returns the device to the most proximal resting location. The surgeon uses hand pressure to control the rate of sliding of the active end within the sheath. Separate channels are provided for irrigant inflow and outflow, permitting continuous fluid circulation for good visibility.