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