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The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator. The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-the-wire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise Multi-Use RF Adapter Cable (packaged separately – Model CW-1001) and a commercially available Electrosurgical Pencil.

The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) is used in Transseptal Puncture Procedures (TSP) to connect the CrossWise™ RF Transseptal Cannula (K241414) to a 3/32" electrosurgical (ES) pencil. The cable delivers radiofrequency (RF) energy to the CrossWise™ RF Transseptal Cannula to facilitate septal puncture. The CrossWise RF Transseptal Cannula is connected to a ValleyLabs Force2 ES Generator (K051644) via the CrossWise Multi-Use RF Adapter Cable (Model CW-1001) or CrossWise RF Adapter Cable (Model CW-1002 / K241414) and a commercially available 3/32" ES pencil. The CrossWise Multi-Use RF Adapter Cable has unique connectors on each end which cannot be connected to an improper device and/or accessory. The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) and CrossWise RF Adapter Cable (Model CW-1002) are both compatible with all CrossWise RF Transseptal Access System models. The dimensions for the CrossWise Multi-Use RF Adapter Cable can be found on the package labels. Circa Scientific sterilized the CrossWise Multi-Use RF Adapter Cable via ethylene oxide (EO) for initial use and is intended for multiple patients use, following prescribed reprocessing instructions. The prescribed reprocessing includes cleaning and steam/autoclaye sterilization procedures that have been validated for up to10 uses when users follow the cleaning and sterilization methods described in the Cleaning and Sterilization Instructions sections of the CrossWise Multi-Use RF Adapter Cable IFU. The CrossWise Multi-Use RF Adapter Cable does not come into direct or indirect contact with the patient according to the definitions in Section 3.0 of ISO 10993-1, and Attachment G of the September 2023 FDA Guidance document.

The VersaCross™ RF Wire is indicated for creation of an atrial septal defect in the heart.

The subject VersaCross™ RF Wire is a single-use device that is supplied sterile to the user. The subject device is comprised of an RF Wire and separately cleared Connector Cable (K023334) that are packaged together. The RF Wire is indicated for the creation of an atrial septal defect in the heart. The RF Wire delivers radiofrequency (RF) power in a monopolar mode between its distal active electrode and a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) Electrode/grounding pad. The RF Wire is used with a separately cleared compatible generator, such as the Baylis RF Puncture Generator (K12278). The VersaCross™ RF Wire is comprised of a core stainless steel wire. The RF Wire body is covered with an insulating material to facilitate smooth advancement of the device in conjunction with providing electrical insulation. The floppy distal end of the RF Wire is curved and the active tip is rounded to be atraumatic to cardiac tissue unless RF energy is applied. A marker coil and radio-opaque band is positioned on the distal curve and distal tip, respectively, to facilitate RF Wire placement at the target puncture site during procedures under appropriate imaging quidance such as fluoroscopy, echocardiography and/or electroanatomic mapping (EAM) quidance. The main body of the RF Wire provides a rail for advancing ancillary devices into the left atrium following creation of an atrial septal defect. The RF Wire features visible proximal markers along its length to assist with aligning the wire tip in compatible transseptal sheath and/or dilator assemblies. The proximal end of the RF Wire is bare metal to facilitate connection with the included connector cable. The other end of the included connector cable connects to the compatible Baylis RF Puncture Generator.

The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator. The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-thewire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise RF Adapter Cable (packaged separately - Model CW-1002) and a commercially available Electrosurgical Pencil. The CrossWise RF Transseptal Cannula is designed to facilitate injection of heparinized saline and/or contrast solution. The dimensions for the CrossWise RF Transseptal Cannula can be found on the device label. The CrossWise RF Transseptal Access System offers four configurations compatible with various commercially available guide sheaths (Table 5). All four configurations require use of a single model (CW-1002) CrossWise RF Adapter Cable Model which is packaged separately.

The HOTWIRE™ is indicated for creation of an atrial septal defect in the heart.

The HOTWIRETM is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart. The HOTWIRE is intended to be used in conjunction with compatible third-party intravascular sheaths and/or dilators, such as the Agilis NXT Steerable Introducer, St. Jude Medical (K081645), and third-party RF electrosurgical generator(s), such as the Valleylab FT10 Electrosurgical Platform (K151649) which utilizes a commercially-available Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2, such as the Valleylab E7507DB (K822572). The HOTWIRETM is comprised of a stainless steel core wire. The main body of the wire is jacketed with an insulating polymer that provides electrical insulation and facilitates smooth movement of the device through vascular dilators and/or sheaths. The floppy distal segment of the wire has an atraumatic tip with an uninsulated stainless-steel coil, which serves as an electrode, and also provides fluoroscopic visualization. A tungsten marker coil at the tip provides additional radiopacity. The stiff body of the HOTWIRE™ provides support for advancing wire-guided devices into the left atrium after the distal segment has traversed the septum. The proximal insulated portion of the wire has visual markers that align the electrode tip with 3rd party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for placement of an included Adapter Pin that connects to hand pieces used with compatible third-party RF electrosurgical generators.

The Cross Vascular RF Transseptal Needle and Connection Cable are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The Cross Vascular RF Transseptal Needle is used in transseptal surgical procedures to puncture the fossa ovalis and gain access from the right side of the left atrium. The RF Transseptal Needle within a compatible transseptal introducer set (Table 4) along with radiofrequency (RF) energy from the RF Generator is used to facilitate the septal puncture. The RF Transseptal Needle delivers RF power in a monopolar mode between the device's distal electrode and a commercially available external Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2. The RF Transseptal Needle is loaded through a compatible transseptal sheath and dilator (Table 4) and is connected at its proximal end to the Cross Vascular RF Generator via the Cross Vascular Connection Cable. The distal end of the needle contains a small through hole to facilitate injection of contrast solution. The active tip is specially shaped to be atraumatic to the cardiac tissue until RF energy is applied.

The Fogarty dilation atrioseptostomy catheter is indicated for enlarging interatrial openings for palliation of several congenital cardiac defects to increase mixing at atrial level or to decompress a hypertensive atrial chamber. The Miller balloon atrioseptostomy catheter is indicated for enlarging interatrial openings for palliation of several congenital cardiac defects to increase mixing at atrial level or to decompress a hypertensive atrial chamber.

The Fogarty dilation atrioseptostomy catheter is a 5 French single-lumen catheter (with 8F uninflated balloon OD) with a wire-wound shaft that may be visualized using fluoroscopy. A latex balloon with a maximum inflated diameter of 15mm is located at the distal end of the catheter. The distal tip has a nominal angulation of 35° to facilitate manipulation of the inter-atrial opening. A removable stylet is provided to increase catheter body stiffness and for temporary straightening of the 35° tip angulation during insertion. The catheter contains a gate valve in order to inflate and deflate the balloon. The catheter shaft has depth markings in 10 cm spacing. The Miller balloon atrioseptostomy catheter is a 5 French single-lumen catheter (with 9F uninflated balloon OD) with a wire-wound shaft that may be visualized using fluoroscopy. A latex balloon with a maximum inflated diameter of 19mm is located at the distal end of the catheter. The distal tip has a nominal angulation of 35° to facilitate manipulation of the balloon through the inter-atrial opening. A removable stylet is provided to increase catheter body stiffness and for temporary straightening of the 35° tip angulation during insertion. The catheter contains a gate valve in order to inflate and deflate the balloon. The catheter shaft has depth markings in 5 cm spacing. The Miller catheter contains a plug for occluding the vein or percutaneous sheath to reduce venous leakage. The Fogarty dilation atrioseptostomy catheter and Miller balloon atrioseptostomy catheter are packaged in an identical tube configuration.

Recommended for balloon atrioseptostomy, an accepted technique in most pediatric cardiology centers for the palliation of several congenital cardiac defects. Balloon atrioseptostomy is performed in conjunction with diagnostic cardiac catheterization and has been carried out after the diagnosis of several congenital cardiac defects: transposition of the great arteries, total anomalous pulmonary venous drainout pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.

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The Park Blade Septostomy Catheter is intended to enlarge interatrial openings. The device can also be used when balloon atrial septostomy is insufficient or unsuccessful, particularly in older infants and children with a thickened atrial septum. Normally, the existing interatrial opening is used for this procedure. However, if the interatrial septum is intact, the procedure can be performed in conjunction with a transseptal technique.

The Park Blade Septostomy Catheter is a radiopaque polyethylene catheter with a distal tip section made of a stainless-steel cannula and a proximal end section consisting of a pin vise, a gasket, and a Y sidearm adapter. The distal stainless-steel cannula contains a stainless-steel blade that is linked to a lever, which allows the distal end to form a triangle. The Park Blade Septostomy Catheter is manufactured in 5.7 or 7.3 French sizes. The catheter working length measures either 65 or 85 centimeters from the distal tip to the distal end of the shrink tube. The blade lengths for the 5.7 French catheters are either 9.4 or 13.4 millimeters; for the 7.3 French size catheter, the blade measures 20.0 millimeters.

The ProTrack RF Anchor Wire is indicated for the creation of an atrial septal defect in the heart.

The ProTrack RF Anchor Wire is a sterile, single-use device that delivers radiofrequency (RF) power in a monopolar mode to its distal electrode. The device connects to a separately cleared Baylis Medical Company (BMC) RF Puncture Generator at its proximal end through a compatible BMC Connector Cable. The ProTrack RF Anchor Wire is comprised of a core stainless steel wire. The body of the wire is coated with an insulating material to facilitate smooth advancement of the device and to provide electrical insulation. The wire's distal end is atraumatic and curved to prevent the wire from slipping back into the right atrium through the atrial septal defect when devices are being retracted or advanced over it. A marker coil is positioned on the distal curve for visualization under fluoroscopy. The main body of the RF Anchor Wire provides a stiff rail for advancing ancillary devices into the left atrium following creation of an atrial septal defect. The proximal end is curved and is bare metal to connect with the included BMC Connector Cable for connection to the compatible BMC RF Puncture Generator.