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. These products are intended for use by or under the direction of a physician. Greatbatch medicals proprietary steerable sheath platform provides critical control and support for the delivery of therapeutic devices into peripheral and coronary vascular systems. 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. Efficacy and safety of remote magnetic catheter navigation. 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. Tacticath quartz catheter for percutaneous radiofrequency. Patients with atrial thrombus or myxoma, or interatrial baffle or patch. Agilis nxt steerable introducers dualreach 71 cm sheath 8. The application of optimum contact force cf can be used to improve ablation procedure success and safety. The agilis nxt introducer is designed to replace a fixed curve introducer. 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. Access through innovation proprietary single pullwire steerable platform articulating sheath tip allows for.
Agilis nxt steerable introducer abbott cardiovascular. All the spots with a his recording are tagged on the electroanatomic map, creating a his cloud. 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. 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. Right anterior oblique rao view showing the steerable sheath. Sterilmed agilis sheath death lawsuit lawyers parker. Fda initiates class i recall of sterilmed reprocessed agilis. The agilis epi steerable introducer has been designed to be used on the epicardial covering of the heart. 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. The steerable introducer is fitted with a hemostasis. 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.
How to map and ablate parahisian ventricular arrhythmias. The apple score a novel score for the prediction of rhythm. St judes steerable transseptal sheath, agilis diameter 8. A long 8 fr sr0 sheath was exchanged for the 8 fr short sheath and advanced to the right atrium in a similar fashion. A problem with that device could cause serious health consequences for patients, including death, according to the fda. Worsening of mitral valve regurgitation after radiofrequency. 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. A separate disposable dispersive pad indifferent patch electrode which completes the ablation circuit. Jude helps doctors in gaining access even to parts of the heart that are difficult to reach. Sterilmed reprocessed agilis steerable introducer sheath. 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. 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.
Systemic heparinization was maintained throughout the procedure with a target activated clotting time. Bard ds1002200 direx steerable sheath medicalecart. Study finds sureflex steerable guiding sheath has greater. Since 2002, weve offered the most technologically advanced products available, backed with the most responsive technical support. Four distal electrodes enable realtime steerable sheath visualization. The agilis nxt introducers steerable sheath tip can be adjusted to aid various anatomic approaches with just one introducer. Sterimed reprocessed agilis lawsuits introducer sheath.
Jude transseptal access sign in to add this product to your favorites. Agilis is an ideal fit for agile companies that have complex software licensing requirements. These obstacles can be overcome by using a steerable sheath agilis, st. 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. The heartspan steerable sheath introducer is designed to offer a softer, flexible tip to reduce the risk of atrial wall perforation. Left atrial strain predicts recurrence of atrial arrhythmias. Paul, mn was advanced through the outer sheath, to access the right atrium. It is indicated when introducing various cardiovascular catheters. 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.
The destino twist is the ultimate tool in gaining access to the most difficult to reach sites while maintaining hemostasis with oscor sureseal technology. 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. Jude, 408310, sjm agilis nxt steerable introducer 8. Sjm epicardial catheter system with agilis nxt steerable introducer and response crd electrophysiology catheter. The sterimed reprocessed agilis steerable introducer sheath is a valuable tool if appropriately designed. 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. Pdf a randomized trial to compare atrial fibrillation ablation using. 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. Agilis offers bestinclass software licensing solutions. 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 sheath with adjustable curve allowed for easy positioning of the guiding catheter and resulted in a successful procedure. Agilis nxt steerable introducer instructions for use device description the st. Carto vizigo bidirectional guiding sheath biosense webster. Jude, g402047, sjm epicardial catheter system with. Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions. Direct hepatic vein puncture and transseptal access for. 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.
Sheath introducers were inserted through the right femo. Steerable sheath technology is designed to facilitate catheter access, stability, and tissue contact in target sites of atrial fibrillation af catheter ablation. Catheter navigation was carried out using a steerable sheath agilis, st. Prevention of phrenic nerve damage by pericardial injection of saline and the use of a steerable sheath. Brugada syndrome phenotype elimination by epicardial. Epicardial only mapping and ablation of ventricular. The device, made by sterilmed, was a reprocessed agilis steerable introducer sheath. Sjm epicardial catheter system with agilis nxt steerable introducer and response crd electrophysiology catheter expired st.
The steerable sheath, model direx is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices. Continuous aspiration was then connected to the sheath. The direx steerable sheath is a low profile, bidirectional steerable sheath that provides agility and stability through excellent catheter access and support. Searchable database of fda 510k applications and descisions.
The flexcath advance steerable sheath is a unidirectional, deflectable sheath used to help position an ablation catheter and facilitates better positioning and maneuverability. Agilis software licensing and software license management. The activated clotting time was measured every 2030 minutes throughout the. Agilis epi steerable introducer dualreach 40 cm sheath. A software licensing company about us agilis software. Operatorblinded contact force monitoring during pulmonary. The current study was performed to 1 prove the predictive value of the apple score in patients undergoing repeat af. Jude, g402047, sjm epicardial catheter system with agilis. The cordis stabilizer steerable guidewire is a high support. 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. Bidirectional steering allows dual deflection for maximum maneuverability. When navigating cardiac chambers during electrophysiology ep procedures, the sheath is designed to. Consistent contact force from a steerable sheath is essential to delivering effective ablations, said dr. Paul, mn to displace the eustachian ridge downward and to achieve appropriate support to enter the rv.
Access online digital product and treatment information for patients or healthcares professionals to view, download or print. 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. 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. The agilis nxt steerable introducer combines a low profile with hightech capabilities, giving you greater control during electrophysiology ep procedures. The steerable introducer is fitted with a hemostasis valve to minimize blood. 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. Background arrhythmia recurrences after catheter ablation occur in up to 50% within one year but their prediction remains challenging. The activated clotting time was measured every 2030 minutes throughout the ablation procedure and was maintained at over 300 s.
Jan 23, 2020 consistent contact force from a steerable sheath is essential to delivering effective ablations, said dr. Vascular guidecatheter, singleuse a sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnosticinterventional catheter, lead e. A short steerable sheath 12f agilis epi steerable introducer, abbott, st. Paul, minnesota was introduced into the pericardial space. Recently, we developed a novel score for the prediction of rhythm outcomes after single af ablation demonstrating superiority to other scores. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction andor exchange. This website also uses open source software oss provided by livechat to provide customer support. Direx steerable sheath indications, safety and warnings.
The steerable introducer is a bidirectional transseptal guiding sheath utilized by many ep interventionalists for ablation and mapping procedures. The use of steerable catheters and sheaths has shown to. Carto 3 system mobicath sheath biosense webster, inc. Lesion size index in maximum voltageguided cavotricuspid. It helps you reach hardtoaccess areas of the heart, by providing a stable platform for improved catheter manipulation and contact. Mar 23, 2016 an introducer sheath with a minimum diameter of 8. 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 8f sheath is removed, and the sheath desired for introducing the catheter, usually a long steerable sheath agilis, st. Jude medical agilis es steerable introducer consists of a 94cm, 8. By combining a low profile, a braid reinforced shaft, and a reliable hemostatic seal technology, the direx steerable sheath offers physicians precise. Jude medical was used in all procedures to support manipulation and stability of the ablation catheter. In the steerable sheath group, the swartz left 0 introducer, an 8 french standard sheath, was replaced by an agilis sheath st. 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.
Agilis nxt steerable introducer the agilis nxt steerable introducer consists of a steerable sheath, dilator, and guidewire. 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. For customers not reprocessing agilis sheaths, we offer a buyback program for the following item numbers. The geometry of the left atrium was reconstructed using a 3d mapping system ensite navx, st. The steerable introducer is a bidirectional transseptal guiding sheath. Another class i recall involved a device used to insert and position cardiovascular catheters. Endocardial ablation to eliminate epicardial arrhythmia. Remote navigation and contactforce control of radiofrequency. 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. Anterior epicardial access, using a steerable sheath agilis, st jude medical. 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. The identification of conduction gaps after pulmonary vein. The braided construction provides kink resistance and curve durability during atrial fibrillation procedures.
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. Sheath introducers were inserted through the right femoral vein under sedation. Endomyocardial biopsyintegrating electrode at the bioptome. Atrial and ventricular leads of intracardiac defibrillator are visible. 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. 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. Sterimed reprocessed agilis lawsuits introducer sheath lawyers. In evaluating the contact force of two commonly used steerable sheaths, the sureflex steerable guiding sheath. Instructions for use reprocessed agilis nxt steerable. The agilis nxt steerable introducer consists of a steerable sheath, dilator, and guidewire. Kalila medical announces ce mark approval for the vado. Steerable versus nonsteerable sheath technology in atrial. The oscor destino twist is a steerable guiding sheath that offers a deflectable tip with an ergonomic handle.
Agilis systems tracks thousands of vehicles, assets and employees each day. Software solutions for directional and surveying services. Faulty seal prompts class i recall of sterilmed agilis device. 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. It is not intended for infusion, is not a microcatheter i.
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. Kalila medical announces ce mark approval for the vado steerable sheath used during atrial fibrillation procedures news provided by. The steerable introducer is filtered with a hemostasis valve to minimize. 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. With 5 degrees of deflection and improved deflection response, the sheath may facilitate better access to inferior veins. A steerable introducer sheath may be used to aid catheter handling. At a midlevel of the ppm, an excellent pace map was obtained and the earliest ventricular activation with slightly dull prepotential was identi. It is designed to provide flexible catheter positioning in the cardiac anatomy. Paul, mnand using the same system and catheters as those used in the. Efficacy and safety of remote magnetic catheter navigation vs. Were a leader in the development of innovative, easytouse gps based products that help businesses improve efficiency and save money. The carto vizigo sheath allows for sheath visualization on the carto 3 system map during a procedure without depending solely on. Developing windows database and engineering applications from conception through research, development.