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