The steerable introducer is a bidirectional transseptal guiding sheath utilized by many ep interventionalists for ablation and mapping procedures. Left atrial strain predicts recurrence of atrial arrhythmias. Direx steerable sheath indications, safety and warnings. Fiftysix af patients were randomized to ablation using either an agilis nxt st jude medical, st paul, mn, usa steerable sheath or a fixedcurve mullins. Bard ds1002200 direx steerable sheath medicalecart. It is not intended for infusion, is not a microcatheter i.
Agilis nxt steerable introducer the agilis nxt steerable introducer consists of a steerable sheath, dilator, and guidewire. Ambucor health solutions provides consultative and contracted ambulatory electrocardiographic and remote device monitoring services for cardiologists and institutions keen on retaining ownership of the clinical services they offer. The oscor destino twist is a steerable guiding sheath that offers a deflectable tip with an ergonomic handle. A separate disposable dispersive pad indifferent patch electrode which completes the ablation circuit. All the spots with a his recording are tagged on the electroanatomic map, creating a his cloud. Access online digital product and treatment information for patients or healthcares professionals to view, download or print. Atrial and ventricular leads of intracardiac defibrillator are visible. Jan 08, 2018 the class i recallthe agencys most serious classification targets the reprocessed agilis steerable introducer sheath, which is used to insert and position cardiovascular catheters in the heart, explains fda on its website. Right anterior oblique rao view showing the steerable sheath. The steerable introducer is fitted with a hemostasis valve to minimize blood. Recently, we developed a novel score for the prediction of rhythm outcomes after single af ablation demonstrating superiority to other scores. Epicardial only mapping and ablation of ventricular. Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.
Agilis nxt steerable introducers dualreach 71 cm sheath 8. The agilis nxt introducers steerable sheath tip can be adjusted to aid various anatomic approaches with just one introducer. Searchable database of fda 510k applications and descisions. With 5 degrees of deflection and improved deflection response, the sheath may facilitate better access to inferior veins. These products are intended for use by or under the direction of a physician. The identification of conduction gaps after pulmonary vein. In evaluating the contact force of two commonly used steerable sheaths, the sureflex steerable guiding sheath and the agilis nxt steerable introducer, we found a higher ratio of efficient ablation lesions suggested by a greater stability in contact force with the sureflex sheath.
The application of optimum contact force cf can be used to improve ablation procedure success and safety. Direct hepatic vein puncture and transseptal access for. Jude medical agilis es steerable introducer consists of a 94cm, 8. Jude helps doctors in gaining access even to parts of the heart that are difficult to reach. Agilis nxt steerable introducer instructions for use device description the st. Steerable versus nonsteerable sheath technology in atrial. Efficacy and safety of remote magnetic catheter navigation vs. The flexcath steerable sheath helps deliver and position the medtronic artic front cryocatheter in the left atrium and features unidirectional deflection 5 degrees maximum, 5 cm reach at 90 degrees deflection and 65 cm usable length 80 cm with handle. Four distal electrodes enable realtime steerable sheath visualization. Agilis nxt steerable introducer abbott cardiovascular. It helps you reach hardtoaccess areas of the heart, by providing a stable platform for improved catheter manipulation and contact.
Sterilmed reprocessed agilis steerable introducer sheath. Jude medical sjm agilis steerable catheter introducer set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. Emmanuel koutalas, livio bertagnolli, phillip sommer, sergio richter, sascha rolf, ole breithardt, andreas bollmann, gerhard hindricks, arash arya, efficacy and safety of remote magnetic catheter navigation vs. Substrate epicardial mapping was performed during sinus rhythm and areas of low voltage were identified using standard voltage cutoff values for dense scar apr 12, 2019 another year, another list of medical device recalls unfortunately. The apple score a novel score for the prediction of rhythm. Patients with atrial thrombus or myxoma, or interatrial baffle or patch. Faulty seal prompts class i recall of sterilmed agilis device. How to map and ablate parahisian ventricular arrhythmias. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction andor exchange.
Agilis software is a software licensing company established over 10 years ago that developed one of the most flexible and secure license servers in the market. Operatorblinded contact force monitoring during pulmonary. Lesion size index in maximum voltageguided cavotricuspid. The braided construction provides kink resistance and curve durability during atrial fibrillation procedures. Agilis is an ideal fit for agile companies that have complex software licensing requirements. The reprocessed agilis nxt steerable introducer set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. For customers not reprocessing agilis sheaths, we offer a buyback program for the following item numbers. The steerable introducer is a bidirectional transseptal guiding sheath. Mar 23, 2016 an introducer sheath with a minimum diameter of 8. The destino twist is the ultimate tool in gaining access to the most difficult to reach sites while maintaining hemostasis with oscor sureseal technology. In evaluating the contact force of two commonly used steerable sheaths, the sureflex steerable guiding sheath and the agilis nxt steerable introducer, we found a.
Sjm epicardial catheter system with agilis nxt steerable introducer and response crd electrophysiology catheter expired st. Worsening of mitral valve regurgitation after radiofrequency. The geometry of the left atrium was reconstructed using a 3d mapping system ensite navx, st. Jude, g402047, sjm epicardial catheter system with agilis. It may be rigid or flexible, nonsteerable or steerable, single or multiple lumens, and the distal section of the tube can have a variety of preformed shapes e. In evaluating the contact force of two commonly used steerable sheaths, the sureflex steerable guiding sheath and the agilis nxt steerable introducer, we found a higher ratio of efficient. If ablation could not be performed with 20 w of power, the line was placed either more antrally or closer to the pv, depending on individual anatomical findings. Jude transseptal access sign in to add this product to your favorites. The sterimed reprocessed agilis steerable introducer sheath is a valuable tool if appropriately designed. When navigating cardiac chambers during electrophysiology ep procedures, the sheath is designed to. Access through innovation proprietary single pullwire steerable platform articulating sheath tip allows for. A problem with that device could cause serious health consequences for patients, including death, according to the fda.
Food and drug administration fda announced in january of 2018 that sterilmeds agilis steerable introducer sheath agilis device must be recalled due to grave safety concerns. Efficacy and safety of remote magnetic catheter navigation. It is designed to provide flexible catheter positioning in the cardiac anatomy. Since 2002, weve offered the most technologically advanced products available, backed with the most responsive technical support. The agilis steerable introducer sheath s hemostatic valve, which prevents blood from flowing back through the valve, may fail due to an improper seal of the sheath hub. The direx steerable sheath s low profile design and atraumatic tip to reduce the potential for trauma during transseptal crossings while facilitating passage of a wide variety of catheters.
A long 8 fr sr0 sheath was exchanged for the 8 fr short sheath and advanced to the right atrium in a similar fashion. The heartspan steerable sheath introducer is designed to offer a softer, flexible tip to reduce the risk of atrial wall perforation. The recall affects devices manufactured and distributed between jan. The lesion size index lsi is a novel dimensionless contact force parameter that allows for an accurate estimation of lesion volume in real time by integrating contact force grams, duration seconds and power watts. Steerable sheath technology is designed to facilitate catheter access, stability, and tissue contact in target sites of atrial fibrillation af catheter ablation. We are a liquidator of sutures and other surgical items from ethicon, covidien autosuture, synthes, stryker, arthrex and are able to pass our savings on to you. These obstacles can be overcome by using a steerable sheath agilis, st. The steerable sheath, model direx is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices. The direx steerable sheaths low profile design and atraumatic tip to reduce the potential for trauma during transseptal crossings while facilitating passage of a wide variety of catheters. In the steerable sheath group, the swartz left 0 introducer, an 8 french standard sheath, was replaced by an agilis sheath st. The agilis epi steerable introducer has been designed to be used on the epicardial covering of the heart. Another class i recall involved a device used to insert and position cardiovascular catheters. Sheath introducers were inserted through the right femo.
Jude, g402047, sjm epicardial catheter system with. Aug 21, 2010 the flexcath steerable sheath helps deliver and position the medtronic artic front cryocatheter in the left atrium and features unidirectional deflection 5 degrees maximum, 5 cm reach at 90 degrees deflection and 65 cm usable length 80 cm with handle. Carto 3 system mobicath sheath biosense webster, inc. By combining a low profile, a braid reinforced shaft, and a reliable hemostatic seal technology, the direx steerable sheath offers physicians precise. Continuous aspiration was then connected to the sheath.
Agilis epi steerable introducer dualreach 40 cm sheath. Brugada syndrome phenotype elimination by epicardial. Kalila medical announces ce mark approval for the vado. The agilis nxt steerable introducer combines a low profile with hightech capabilities, giving you greater control during electrophysiology ep procedures.
Prevention of phrenic nerve damage by pericardial injection of saline and the use of a steerable sheath. A software licensing company about us agilis software. Catheter navigation was carried out using a steerable sheath agilis, st. Paul, minnesota was introduced into the pericardial space. The agilis steerable introducer sheaths hemostatic valve, which prevents blood from flowing back through the valve, may fail due to an improper seal of the sheath hub. Sjm epicardial catheter system with agilis nxt steerable introducer and response crd electrophysiology catheter. Magnetic sensors of mediguidecompatible catheters both st jude medical show the tip of the ablation catheter saphire blu in yellow and a decapolar catheter livewire in green.
Remote navigation and contactforce control of radiofrequency. A steerable introducer sheath may be used to aid catheter handling. Jude, 408310, sjm agilis nxt steerable introducer 8. In evaluating the contact force of two commonly used steerable sheaths, the sureflex steerable guiding sheath. Agilis software licensing and software license management.
Anterior epicardial access, using a steerable sheath agilis, st jude medical. Systemic heparinization was maintained throughout the procedure with a target activated clotting time. St judes steerable transseptal sheath, agilis diameter 8. Instructions for use reprocessed agilis nxt steerable.
The agilis nxt steerable introducer consists of a steerable sheath, dilator, and guidewire. The steerable sheath with adjustable curve allowed for easy positioning of the guiding catheter and resulted in a successful procedure. The activated clotting time was measured every 2030 minutes throughout the. Developing windows database and engineering applications from conception through research, development.
The 8f sheath is removed, and the sheath desired for introducing the catheter, usually a long steerable sheath agilis, st. Sterilmed agilis sheath death lawsuit lawyers parker. Greatbatch medicals proprietary steerable sheath platform provides critical control and support for the delivery of therapeutic devices into peripheral and coronary vascular systems. Procedural success by sheath type steerable sheath group agilis nxt steerable introducer nonsteerable sheath group 78% 76% 53% 55% freedom from af andor atrial mrt presence of af andor atrial mrt after 3 months p0. Vascular guidecatheter, singleuse a sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnosticinterventional catheter, lead e. Paul, mn to displace the eustachian ridge downward and to achieve appropriate support to enter the rv.
Paul, mnand using the same system and catheters as those used in the. The flexcath advance steerable sheath is a unidirectional, deflectable sheath used to help position an ablation catheter and facilitates better positioning and maneuverability. At a midlevel of the ppm, an excellent pace map was obtained and the earliest ventricular activation with slightly dull prepotential was identi. The steerable introducer is filtered with a hemostasis valve to minimize. The use of steerable catheters and sheaths has shown to. The carto vizigo sheath allows for sheath visualization on the carto 3 system map during a procedure without depending solely on. The agilis nxt introducer is designed to replace a fixed curve introducer. It is indicated when introducing various cardiovascular catheters. Agilis systems tracks thousands of vehicles, assets and employees each day.
A short steerable sheath 12f agilis epi steerable introducer, abbott, st. Jan 23, 2020 consistent contact force from a steerable sheath is essential to delivering effective ablations, said dr. The reprocessed agilis nxt steerable introducer consists of a steerable sheath, dilator, and guidewire which is designed to provide flexible catheter positioning in the cardiac anatomy. The direx steerable sheath is a low profile, bidirectional steerable sheath that provides agility and stability through excellent catheter access and support. Software solutions for directional and surveying services. Endomyocardial biopsyintegrating electrode at the bioptome. The device, made by sterilmed, was a reprocessed agilis steerable introducer sheath. This tool assists cardiologists insert a cardiac catheter in the heart that helps them determine the heart health of the patient and how your heart is working at the time. The steerable introducer is fitted with a hemostasis. The cordis stabilizer steerable guidewire is a high support. Were a leader in the development of innovative, easytouse gps based products that help businesses improve efficiency and save money. Consistent contact force from a steerable sheath is essential to delivering effective ablations, said dr.
Jude medical was used in all procedures to support manipulation and stability of the ablation catheter. Agilis offers bestinclass software licensing solutions. Background arrhythmia recurrences after catheter ablation occur in up to 50% within one year but their prediction remains challenging. Bidirectional steering allows dual deflection for maximum maneuverability. Sheath introducers were inserted through the right femoral vein under sedation. Sterimed reprocessed agilis lawsuits introducer sheath lawyers. Over 40 years of experience in the oil and gas service industry and more than 30 years of experience in developing software applications for directional and surveying services. Carto vizigo bidirectional guiding sheath biosense webster. Stabilizer peripheral steerable guidewire please note that access to the following pages is exclusively reserved to cordis employees and healthcare professionals in europe, the middle east, and africa that are willing.
Prior to use, reference the instructions for use, inside the product carton when available or online for more detailed information on indications, contraindications, warnings, precautions and adverse events. Sterilmeds agilis steerable introducer sheath is designed for the insertion and positioning of cardiovascular catheters in the heart, including the left side of the heart through the. Paul, mn was advanced through the outer sheath, to access the right atrium. This website also uses open source software oss provided by livechat to provide customer support. Kalila medical announces ce mark approval for the vado steerable sheath used during atrial fibrillation procedures news provided by. Jan 23, 2020 in evaluating the contact force of two commonly used steerable sheaths, the sureflex steerable guiding sheath and the agilis nxt steerable introducer, we found a higher ratio of efficient ablation lesions suggested by a greater stability in contact force with the sureflex sheath. Tacticath quartz catheter for percutaneous radiofrequency. Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system air embolism. Study finds sureflex steerable guiding sheath has greater. Jude medical sjm agilis nxt steerable introducer set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. Pdf a randomized trial to compare atrial fibrillation ablation using. The activated clotting time was measured every 2030 minutes throughout the ablation procedure and was maintained at over 300 s. Fda initiates class i recall of sterilmed reprocessed agilis.
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