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The VIKING Fixed Curve Diagnostic Catheter is indicated for use to diagnose cardiac arrhythmias.

The Viking Fixed Curve Diagnostic Catheters (also referred to as Viking Catheters) are intended for use in electrophysiology procedures to record, stimulate and pace in the diagnosis of cardiac arrhythmias. The Viking Catheters receive electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter into the vasculature percutaneously. To reach the right side of the heart, either the internal jugular vein, the subclavian veins, or the femoral veins can be accessed. To reach the left ventricle, the retrograde approach via the femoral artery can be used. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism, as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface. Viking Catheters are radiopaque, flexible, insulated catheters. The catheters have a polymer shaft that houses the electrical wiring that connects the electrodes to a connector at the proximal end of the catheter; each electrode wire is soldered into this connector. When the catheter is used, the connector is attached to a sterile cable that connects to the hospital recording and pacing equipment. The Viking Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).

The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia(BPH). It is indicated for men ≥ 50 years of age with a prostate volume 30 cm³ ≤ 150 cm³. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure. Following thermal therapy for BPH, small pieces of coagulated tissue may slough off and be expelled via urination. This sloughing process may continue for a few months post-procedure depending on the rate of healing. The Rezūm System consists of the following: • **Rezūm Generator** – reusable, non-sterile capital equipment, provided with one power cord • **Rezūm Delivery Device Kit** – sterile, single-use kit containing the following disposable components: - One sterile Delivery Device with cable and tubing - One sterile syringe - One sterile spike adaptor - One sterile water vial

The OptiMap System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias. The OptiMap™ System is intended to be used during electrophysiology procedures on patients for whom an electrophysiology procedure has been prescribed and only by qualified medical professionals who are trained in electrophysiology.

The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an Amplifier, Cart, Monitor, and Workstation that contains proprietary mapping software. Signals from a 64-electrode mapping basket catheter are transmitted to the Workstation by the Amplifier, processed by the mapping software, and the results are displayed on the Monitor. The OptiMap System utilizes proprietary algorithms to process intra-cardiac electrogram (EGM) signals from a 64-electrode unipolar mapping basket catheter. The software transforms the time domain waveform information from the electrodes into space domain information which calculates the Electrographic Flow™ (EGF™) vectors for Atrial Fibrillation. The system also has algorithms that display action potential wavefront propagation or Activation Cycle Path (ACP). The ACP maps are a reconstruction of the activation wavefront propagation and may be used to visualize organized atrial arrhythmias. The software output includes static and dynamic EGF maps that graphically depict the temporal activity and location of sources of EGF with respect to the catheter electrodes. The software displays active sources of flow and passive flow phenomena, detects spatial and temporal stability of sources of flow and detects the prevalence of sources of flow. In addition, the software output includes ACP maps displaying isochrones and a wavefront animation for each cycle.

The Ureteral Stents are intended to facilitate urinary drainage from the kidney to the bladder via placement endoscopically or fluoroscopically by a trained physician. The Urinary Diversion Stent Sets are intended to provide external drainage of urine after urinary diversion surgeries.

The Ureteral Stents are sterile, single use, disposable devices that provide a lumen that allows fluids to move from the kidney to the bladder. The Ureteral Stents are provided in multiple French sizes and lengths. The Urinary Diversion Stent Sets are sterile, single use, disposable devices that allow internal drainage from the kidney to an external collection system.

The Navigator HD Ureteral Access Sheath is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

Navigator™ HD Ureteral Access Sheath Set consists of a semi-rigid outer sheath and a semi-rigid inner dilator with interlocking hub. The set permits utilization of a guidewire to assist in device placement. Sheath: The Navigator™ HD Sheath has a sheath hub which is over-molded onto the sheath shaft has three layers: Outer Pebax layer, Reinforced stainless steel coil enhancing torqueability and maneuverability, Inner PTFE liner. The sheath outer layer contains Barium Sulphate as a radiopacifier. In addition to the stainlesssteel coil, a radiopaque marker band is sandwiched between the Pebax and PTFE layers. The radiopaque marker band is located at the sheath tip and, along with the radiopacifier added to the sheath outer layer, enhances fluoroscopic visualization of sheath placement during the procedure. A hydrophilic coating is applied to the entire length of the shaft to reduce friction and facilitate placement of the device. Dilator: The Navigator™ HD dilator has a hub with a standard luer lock at the proximal end. The tab on the dilator hub allows it to lock into the sheath hub. The dilator shaft is made of extruded tube Pellethane to allow for dimensional stability, low moisture absorption, and chemical resistance. The dilator tip is made of a softer grade of Pellethane to improve tip flexibility to assist in atraumatic placement. Both the dilator shaft and tip contain Barium Sulfate as a radiopacifier, enhancing visualization under fluoroscopy during the procedure. A hydrophilic coating is applied to the entire length of the dilator to reduce friction and facilitate placement of the device, either when assembled with the sheath or when used separately as a dilatation device.

The Resolution™ Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: 1. Endoscopic marking 2. Hemostasis for: - Mucosal/sub-mucosal defects < 3 cm - Bleeding ulcers · Arteries < 2 mm - Polyps < 1.5 cm in diameter - · Diverticula in the colon - Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus 4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively.

The Resolution™ Clip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle assembly and delivery catheter. The clip delivery system is offered in a 155cm and 235cm working length. The clip consists of a stainless-steel capsule and clip arms, a cobalt chrome yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening and closing may be limited by clinical circumstances and patient anatomy, among other factors. The Resolution™ Clip is designed to be compatible with endoscopes with working channels equal to or greater than 2.8 mm. There are no associated accessories included with this device.

The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling.

The AdVance XP Male Sling System is provided as a sterile, single-pack kit composed of the following primary components: Male Sling, Needle Passers (2), Retractor Ring, and Stay Hooks. The subject of this premarket notification is around the Male Sling component of the AdVance XP Male Sling System, specifically the implantable portion of the Male Sling assembly, which is the mesh sling and the tissue anchors. There are no modifications to the Needle Passers, or Retractor Ring and Stay Hooks (which form the Retraction System) as a part of this submission. Note that the Retraction System are comprised of purchased, off-the-shelf components cleared through K791665.

EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.

The unidirectional steerable diagnostic catheters acquire electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter(s) percutaneously via either the anterior approach using the internal jugular vein or the subclavian vein or via the femoral vein or for a retrograde approach, via the femoral artery. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface. The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The EP+XT Catheter has a white rotating handle mechanism which provides curve actuation of the distal tip. The Dynamic Tip and Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip. The EP•XT, Dynamic Tip, and Dynamic XT Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).

The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeed Cryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles) are meant to be connected to a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System when performing cryoablative tissue destruction through application of extremely cold temperatures. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application. The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE Cryoablation System, are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The CX Needles are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures. The CX Needles have the following specific indications: · Urology - Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH) · Oncology - Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy. · Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of the skin • Gynecology – Ablation of malignant neoplasia or benign dysplasia of the female genitalia · General surgery - Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas - ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth - · Thoracic surgery (with the exception of cardiac tissue) - Proctology Ablation of benign or malignant growths of the anus or rectum

Boston Scientific Corporation's (BSC) IceSeed 1.5 CX Straight Cryoablation Needle, IceSphere 1.5 CX Straight Cryoablation Needle, and IceRod 1.5 CX Straight Cryoablation Needle (hereafter referred collectively as the Straight Needles) are sterile, single use, disposable devices used in conjunction with a Boston Scientific cryoablation system for cryoablative destruction of tissue during surgical procedures under CT guidance. The Straight CX Needles are disposable 1.5 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. The needles convert high-pressure gas to either a very cold freezing application or to a warm thawing application. Active tissue thawing may also be achieved by activating the heating element inside the Straight CX Needles.