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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.

The WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary are indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

The WALLSTENTTM RP Endoprosthesis Transhepatic Biliary and WALLSTENTTM Endoprosthesis Transhepatic Biliary are comprised of two components: The implantable metallic stent and the Unistep Plus delivery system. The stent is composed of biomedical superalloy wire, braided in a tubular mesh configuration. This design configuration results in a stent that is flexible, compliant, and self-expanding. The delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. Small stent sizes (8 & 10mm) may have a radiopaque core to improve radiopacity. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035in (0.89mm) guidewire.

The AXIOS Stent with Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6cm in size, with ≥ 70% fluid content that are adherent to the gastric or bowel wall. Once placed, the AXIOS Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution.

The AXIOS Stent with Electrocautery Enhanced Delivery System is intended for the endoscopic placement of a flexible. MR conditional, fully-covered, self-expanding braided Nitinol stent for transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts. The AXIOS Stent with Electrocautery Enhanced Delivery System is comprised of two main components: (1) AXIOS Stent and (2) Electrocautery Enhanced Deliverv System. The subject premarket notification describes modifications to the cleared AXIOS Delivery System to add electrocautery to facilitate precise access to anatomic targets as well as the staged placement of the currently cleared AXIOS Stent. The AXIOS Stent with Electrocautery Enhanced Delivery System incorporates the same identical implantable stent that is preloaded within the current AXIOS Delivery System (K123250). Both the AXIOS Stent and Delivery System were originally cleared under 510(k) K123250 and most recently under 510(k) K140561. As with the non-cautery AXIOS devices, the Electrocautery Enhanced AXIOS Delivery System is compatible with commercially-available 0.035-inch endoscopic guidewires and intended to be used in the gastrointestinal tract in conjunction with commercially available echoendoscopes. The Electrocautery Enhanced Delivery System has been modified to connect with an off-the- shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2. The generator must be installed and put into service according to the EMC information provided in the generator manufacturer's guidance and declaration for electromagnetic compatibility. Cables and patient return electrodes that are specified by generator manufacturer must be used for connection. The AXIOS Stent with Electrocautery Enhanced Delivery System is provided sterile, disposable and intended for single use. The Electrocautery Enhanced AXIOS Delivery System is IEC compliant.

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The Chariot™ Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the peripheral vasculature.

The Chariot™ Guiding Sheath is designed to perform as an introducer sheath for delivering interventional and diagnostic devices into the peripheral vasculature. The guiding sheath has a coiled shaft design and comes with a straight (ST) or preformed multipurpose (MP) tip shape. It is equipped with a cross-cut hemostatic valve or Tuohy-Borst adapter to prevent bleeding and a sidearm with a three-way stopcock to allow for flushing and introduction of contrast medium. It is also packaged with a dilator to facilitate delivery over a guidewire. The guiding sheath can accommodate guidewires with diameters less than or equal to 0.038 in (0.97 mm). The outer surface of the guiding sheath has a hydrophilic coating from the distal tip to approximately 9 cm from the hub. The distal tip has a radiopaque marker band approximately 6 mm from the distal edge, to help with guiding sheath placement. A copolyester elastomer hub is over molded onto the proximal section of the guiding sheath. It incorporates a luer fitting which serves as a junction to the hemostatic valve.

The Initial Placement PEG is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.

The EndoVive Standard Percutaneous Endoscopic Gastrostomy (PEG) Kit with ENFit and Safety PEG Kit with ENFit are single-use, sterile, disposable kits. These kits contain a feeding tube, accessories used during initial placement of the tube, and accessories used after placement to aid in the provision of nutrition and medication directly into the stomach of adult and pediatric patients who are unable to consume nutrition by conventional means. In addition to the accessories packaged with the kits, replacement Y-Ports, c-clamps and round external bolsters are also available separately. The Y-Port accessory, which is attached to the external end of the feeding tube to allow connection with other enteral feeding devices, is being modified to comply with the new ISO/DIS 80369-3.2 standard requirements to reduce the risk of misconnection with non-enteral feeding devices. The change to the Y-Port is to add the ISO/DIS 80369-3.2 ENFit thread design and to manufacture it in a more rigid material. Neither the feeding tube nor the accessories used for tube placement within these kits is changing. Other than the Y-Port, all other accessories in the Standard and Safety PEG Kits with ENFit are identical to the predicates.

Indicated for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The guidewires are designed to be used during endoscopic biliary procedures for catheter introduction and exchanges. The Jagtail™ High Performance Guidewire Extension attached to the extendable Jagwire™ 260 cm Guidewire is designed for use during endoscopic biliary procedures for non-rapid exchange catheter introduction and exchanges. The attachment of the Jagtail High Performance Guidewire Extension to the extendable Jagwire 260 cm guidewire creates an extended guidewire that can be used to exchange out a non-rapid exchange biliary catheter without removing the original guidewire from the associated duct. When the exchange is completed, the Jagtail High Performance Guidewire Extension can be detached and the original, extendable Jagwire 260 cm guidewire can be used in a conventional manner.

Jagwire™ High Performance Guidewire, and Jagwire™ High Performance Extendable Guidewire: The Boston Scientific Jagwire™ High Performance Guidewire is constructed of a metal alloy core, which is encapsulated in a striped PTFE jacket with a 5 cm hydrophilic radiopaque distal tip. The striped jacket provides endoscopically visible movement markings. Jagtail™ High Performance Guidewire Extension: The Boston Scientific Jagtail™ High Performance Guidewire Extension is a 200 cm long guidewire extension constructed of a stainless steel core with a connector at the distal end. The shaft is coated with a PTFE sleeve. The Jagtail High Performance Guidewire Extension is exclusively compatible with the Jagwire High Performance Extendable Guidewire, 260 cm. The distal end of the Jagtail High Performance Guidewire Extension is inserted into the proximal end of the extendable Jagwire 260 cm guidewire with the use of the alignment tool. The alignment tool is then removed from the Jagtail High Performance Guidewire Extension.

The drainage catheter is intended to provide percutaneous drainage of abscess fluid and biliary collections. The drainage catheter is intended to provide external and internal percutaneous drainage of the biliary system.

Expel™ drainage catheters are nonvascular intervention catheters that consist of a single lumen tube with drainage holes in the distal region and a proximal hub. The catheters are inserted using percutaneous access to provide internal and/or external drainage of fluid collections in body cavities. They can be long-term indwelling devices not to exceed 90 days in the body. Expel™ APD™, APDL, and APD Large Capacity families differentiate the available French sizes, distal shape geometries, and hub types. These families contain the widest range of products with catheter outer diameters ranging from 6 to 26 French, and working lengths ranging from 15 to 45 cm. The distal ends of the catheters contain drainage holes, an adjacent radiopaque marker band, and a tapered tip. The catheter shafts have graduation markings with numeric values and a hydrophilic coating distally. Expel™ APDL family has a distal locking pigtail and a proximal Twist-Loc™ hub. Expel™ APD™ and APD Large Capacity families have a distal J-tip geometry and a proximal non-locking hub. Expel™ Biliary drainage catheters are available in outer diameters of 8 to 14 French and lengths ranging from 20 to 40 cm. The distal end of the catheter contains drainage holes within a locking pigtail, an adjacent radiopaque marker band, and a tapered tip. The catheter shaft has additional drainage holes, graduation markings and numeric values, and a hydrophilic coating distally. The distal locking pigtail is activated by the proximal Twist-Loc™ hub. The Expel™ drainage catheters come with a variety of accessories that aid in percutaneous access, device placement, device securement, and drainage fluid management. Accessories include: - Cannulas - Trocars - Connecting Tubes - Plugs / Caps - Pigtail Straightener - Facial Dilators - Guidewires - Dressing - Catheter Cuff - Introducers / Needles - Cable Ties

Expel™ Nephroureteral Stent System with Twist-Loc™ Hub: The Expel Nephroureteral Stents are delivered percutaneously and are intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage. Expel™ Ureteral Stent System: The Expel Ureteral Stent System is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.

The Expel Nephroureteral and Ureteral Stents are single-lumen, nonvascular intervention stents inserted using percutaneous access to provide internal and/or external drainage of the ureteropelvic junction to the bladder and stenting of the ureter. They are long-term indwelling devices not to exceed 30 days in the body. Expel Nephroureteral Stents are available in outer diameters of 8.3 and 10.3 French, with working lengths ranging from 22 to 28 cm. They contain two pigtails each containing drainage holes. The locking, proximal pigtail forms in the renal pelvis, while the distal, concentric pigtail forms in the bladder. Drainage can occur internally (from the ureteropelvic junction to the bladder) or externally (from the bladder and ureteropelvic junction to the outside of the patient). Each pigtail has an adjacent radiopaque marker band. The distal end of the stent has a tapered tip and hydrophilic coating. The locking, proximal pigtail is activated by the Twist-Loc™ hub on the proximal end of the stent. Expel Ureteral Stents are available in outer diameters of 6.3, 8.3, and 10.3 French, with working lengths ranging from 12 to 28 cm. The distal and proximal ends of the stent contain drainage holes within concentric pigtails. The pigtails form in opposite directions, with the proximal pigtail forming in the renal pelvis, and the distal pigtail forming in the bladder. Drainage occurs through pressure differential via gravity between the body cavities. Each pigtail has an adjacent radiopaque marker band, and the distal end of the stent has a tapered tip and hydrophilic coating. A suture is looped through the most proximal drainage hole which allows for stent adjustment or removal during placement, and the suture is removed once placement is complete. The Expel Nephroureteral and Ureteral Stents come with the following accessories that aid device placement. - Cannulas - Stabilizer - Plug/Cap - Pigtail Straightener The Expel Nephroureteral and Ureteral Stents are similar in fundamental design, function, device materials, sterilization, operating principle, intended use / indication for use and fundamental technology as the predicate device, the Percuflex™ Nephroureteral Stent and Percuflex™ Ureteral Stent. The modifications from the predicate device include: - Modified hub designs - New stent shaft material - Addition of radiopaque marker bands - Extended sizes/platforms - Modified packaging

The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Sterling Monorail Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a high performance balloon catheter for peripheral indications. The device features an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with either 0.014 in (0.36 mm) or 0.018 in (0.46 mm) guidewires. The Sterling Monorail PTA Balloon Dilatation Catheter is a Monorail brand rapid exchange catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in / 0.018 in (.36 mm / .46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. Markers on the 80 cm and 90 cm effective length catheters indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 50 cm and two at 60 cm). Markers on the 135 cm and 150 cm effective length catheters indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm). The effective lengths of the balloon catheter are 80 cm, 90 cm, 135 cm, and 150 cm. A needle with a luer port is included for flushing the distal inner lumen prior to the insertion of appropriate guidewires.