nitinol and Ductus-Arteriosus--Patent

Nitinol alloy occluders are widely used in the transcatheter intervention treatment of congenital heart diseases like patent ductus arteriosus (PDA). However, nitinol alloy contains high levels of nickel, which can lead to toxic effects in the immune and hematopoietic systems if released in sufficient quantities. A new type of single-rivet occluder coated with nano-film has been developed to limit the release of nickel. In total, 23 patients were recruited and randomly assigned to the experimental group (n=12) with the new nano-film single-rivet occluders or the control group (n=11) with the traditional occluders. One case in the control group was lost to follow-up. The remaining 22 cases were followed up at 24 h, 7 days, 1 month, 3 months, and 6 months after the procedure. There were no statistically significant differences in routine blood test, alanine aminotransferase, creatinine, and troponin between the experimental and control groups. Serum nickel concentration in both two groups increased at 24 h after the procedure, peaked at 1 month, and returned to preoperative levels at 6 months. Serum nickel levels in the experimental group were significantly lower than in the control group at 24 h, 7 days, 1 month, and 3 months after the procedure. These data suggested that the nano-film coating effectively prevented nickel release from the new occluders, and therefore has a preferable safety profile.

Topics: Adolescent; Adult; Alloys; Cardiac Surgical Procedures; Child; Child, Preschool; Double-Blind Method; Ductus Arteriosus, Patent; Female; Humans; Infant; Male; Middle Aged; Nanostructures; Nickel; Postoperative Complications; Septal Occluder Device

This study aimed to compare the efficacy and safety of the Nit-Occlud PDA device (PFM Medical, Cologne, Germany) to benchmarks designed as objective performance criteria (OPC).. The Nit-Occlud PDA is a nitinol coil-type patent ductus arteriosus (PDA) occluder with a reverse cone configuration, which is implanted using a controlled delivery system.. Patients with <4-mm minimum diameter PDA were prospectively enrolled in the Pivotal and the Continuing Access Studies from 15 sites in the United States and were followed up for 12 months post-procedure. Investigator-reported outcomes were compared to OPC including a composite success criterion, efficacy criteria of successful closure (clinical and echocardiographic), and safety criteria incidence of adverse events (serious and of total).. The Pivotal Study enrolled patients between November 1, 2002 and October 31, 2005, and the Continuing Access Study enrolled additional patients between September 1, 2006 and October 31, 2007. A total of 357 patients were enrolled, and 347 had successful device implantations. After 12 months, 96.8% had complete echocardiographic closure (OPC = 85%) and 98.1% had clinical closure (OPC = 95%). There were no deaths or serious adverse events (OPC = 1%). The total adverse event rate was 4.7% (OPC = 6%). Composite success was 95.1% in the study patients (OPC = 80%).. Closure of small- and medium-sized PDA with the Nit-Occlud PDA is effective and safe when compared with OPC.

Topics: Adolescent; Alloys; Cardiac Catheterization; Child; Child, Preschool; Ductus Arteriosus, Patent; Female; Humans; Infant; Male; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome; United States; Young Adult

Topics: Alloys; Child; Child, Preschool; Ductus Arteriosus, Patent; Embolization, Therapeutic; Equipment Design; Humans; Infant; Prostheses and Implants

To report the results of the Nit-Occlud PDA prospective postapproval study (PAS) along with a comparison to the results of the pivotal and continued access trials.. The Nit-Occlud PDA (PFM Medical, Cologne, Germany), a nitinol coil patent ductus arteriosus (PDA) occluder, was approved by the Food and Drug Administration in 2013.. The PAS enrolled a total of 184 subjects greater than 6 months of age, weighing at least 5 kg, with PDAs less than 4 mm by angiography at 11 centers. Patients were followed prospectively at 2 months, 12 months, and 24 months postprocedure. These outcomes were compared to the 357 subjects enrolled in the pivotal and continued access protocols. Efficacy and safety data were reported.. Among 184 subjects enrolled for the PAS between 2014 and 2017, 180 (97.8%) had successful device implantation. After 12 months, 98.7% (150/152) had trivial or no residual shunt by echocardiography and two subjects had only small residual shunts. There were three device embolizations that were all retrieved by snare without clinical consequence. Together with the pivotal and continued access study, 97.4% (449/461) had complete echocardiographic closure at 12 months in 541 enrolled subjects. The composite success was 94.4%. There were no mortalities and no serious device-related adverse events.. The Nit-Occlud PDA is a safe and effective device for closure of a small to moderate sized PDA. There were no serious device-related adverse events in a large cohort of three clinical trials.

Topics: Adolescent; Alloys; Cardiac Catheterization; Child; Child, Preschool; Device Approval; Ductus Arteriosus, Patent; Equipment Design; Female; Humans; Infant; Male; Non-Randomized Controlled Trials as Topic; Product Surveillance, Postmarketing; Prospective Studies; Time Factors; Treatment Outcome; United States; Young Adult

Patent ductus arteriosus (PDA) is a congenital cardiovascular defect in which a fetal connection between the aorta and pulmonary artery does not spontaneously close shortly after birth. If left uncorrected serious complications and even death can occur. Surgical ligation is the traditional treatment method; however, it is an invasive procedure, that motivates development of a minimally invasive option. Shape memory polymer (SMP) foams are unique materials that hold promise in the field of minimally invasive occlusion devices. In this work, a prototype nitinol foam cage (NFC) incorporating SMP foams has been designed and evaluated in multiple mechanical and in vitro verification tests. The NFC demonstrated acceptable fatigue resistance in a preliminary strut integrity test, withstanding one million cycles without complete strut fracture. Radial force analysis of both thick- and thin-walled prototype variations generated less vessel distension and wall tension in a vessel mimic compared to a commercial device. The NFCs exhibited negligible in vitro migration, comparable to that of a commercial device, using simplified, ideal models of PDA. Deployment characteristics of the prototypes were evaluated and compared to that of a commercial device when delivered into physiological models of PDA. During mock deployments, a veterinary cardiologist noted that, while deliverable, the thin-walled NFC prototype exhibited poor deployment characteristics, however the thick-walled NFC had deployment characteristics comparable to that of a commercial device. The promising results of this study warrant further investigation of the NFC device for canine PDA closure.

Topics: Alloys; Animals; Dogs; Ductus Arteriosus, Patent; Polymers; Pulmonary Artery; Stents; Therapeutic Occlusion

This study assessed the feasibility and efficacy of implanting a new miniaturized nitinol device to occlude the patent ductus arteriosus (PDA) in a newborn porcine model.. Transcatheter device closure is the standard of care for PDA in older children and adults. Currently available technology is not designed for the newborn infant.. The Amplatzer Duct Occluder II 0.5 is a new transcatheter Nitinol device without fabric designed to close the PDA with small aortic and pulmonary artery structures. The device was implanted in 8 infant pigs (average weight 2,400 g) after balloon dilation of PDA (average diameter 2.7 mm, average length 5.8 mm) with immediate, ∼ 7, ∼ 30, and ∼ 90 day follow-up by echocardiography, angiography, and final pathological examination. Half were implanted arterial, and half venous.. The device was successfully implanted in all animals. There was complete occlusion of the PDA in all cases without obstruction of the pulmonary arteries or aorta. There was complete late endothelialization without thrombus. The only complication was transection of a femoral artery accessed by cutdown.. The success of this animal study confirms safety and feasibility of the Amplatzer Duct Occluder II 0.5 (now known as the ADO II AS) for use when the aorta and pulmonary arteries are small. Consideration can be given to transcatheter closure of the PDA in preterm and other small infants with this device.

Topics: Alloys; Animals; Animals, Newborn; Aorta; Aortography; Cardiac Catheterization; Ductus Arteriosus, Patent; Feasibility Studies; Materials Testing; Miniaturization; Models, Animal; Prosthesis Design; Pulmonary Artery; Septal Occluder Device; Swine; Time Factors; Ultrasonography

The aim of this study was to evaluate a new type of occluder for patent ductus arteriosus. Patent ductus arteriosus was established in a canine model by anastomosing a length of autologous jugular vein to the descending aorta and the left pulmonary artery in an end-to-side fashion. Transcatheter closure of each patent ductus arteriosus was performed on 10 dogs, which were then monitored for as long as 6 months with aortography, echocardiography, and histologic evaluation. Transcatheter closure with use of the novel pan-nitinol device was successful in all canine models. Postoperative echocardiography showed that the location and shape of the occluders were normal, without any residual shunting. Further histologic evaluation confirmed that the occluder surface was completely endothelialized 3 months after implantation. Transcatheter patent ductus arteriosus closure with the pan-nitinol occluder can be performed safely and successfully in a canine model and shows good biological compatibility and low mortality rates.

Topics: Alloys; Anastomosis, Surgical; Animals; Aorta, Thoracic; Aortography; Cardiac Catheterization; Disease Models, Animal; Dogs; Ductus Arteriosus, Patent; Echocardiography; Equipment Design; Feasibility Studies; Jugular Veins; Materials Testing; Microscopy, Electron, Scanning; Pulmonary Artery; Septal Occluder Device; Time Factors

To describe early clinical experience with the amplatzer ductal occluder II additional sizes (ADO II AS) for percutaneous arterial duct occlusion in infants and small children.. Pre-, intra- and postprocedural data analysis of all patients undergoing arterial duct occlusion with the ADO II AS from three tertiary referral centers.. 17 patients (10 female) with a median age of 6 months (range 1.0-48.1 months) and a median weight of 5.7 kg (range 1.7-17.4 kg) underwent attempted transcatheter ductal closure with the ADO II AS. Retrograde arterial approach was used in eight patients with transvenous femoral approach used in nine. The mean minimal ductal diameter was 2.2 ± 0.7 mm with mean ductal length of 6.8 ± 1.7 mm. Device sizes used were 5/6 (n = 5), 3/4 (n = 4), 4/4 (n = 3), 4/6 (n = 3), and 5/4 (n = 2) with four French delivery sheaths used in all cases. The median fluoroscopy time was 5.7 ± 1.8 min. Two patients underwent delivery under exclusive echocardiography guidance. Complete ductal occlusion was achieved by the end of the procedure in 13 patients. Device embolization to the left pulmonary artery occurred in one patient with successful surgical removal and ligation of the arterial duct. Three patients required device resizing following deployment of the initial device. Complete ductal occlusion without aortic arch or left pulmonary artery stenosis has been identified in all 16 remaining patients on transthoracic echocardiographic follow-up at median of 4.2 months.. The new amplatzer ductal occluder II AS achieves excellent ductal closure rates through low profile delivery systems in small infants and children with variable ductal anatomy.

Topics: Age Factors; Alloys; Cardiac Catheterization; Child, Preschool; Device Removal; Ductus Arteriosus, Patent; England; Female; Foreign-Body Migration; Humans; Infant; Ireland; Ligation; Male; Prosthesis Design; Pulmonary Artery; Radiography, Interventional; Retrospective Studies; Tertiary Care Centers; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Interventional closure of patent arterial duct has become an accepted alternative to surgical closure. Clinical trial with "Nit-Occlud® PDA-R".. To assess the safety and efficacy of the device, we performed a prospective clinical study between June, 2009 and December, 2010 in La Paz, Bolivia. In all, 29 - 22 female patients and 7 male patients - out of 59 patients were selected on the basis of inclusion criteria. The procedures were performed under sedation at an age and weight of 5.7 years and 22.7 kilograms, respectively, with 4-6 French arterial sheaths and 5-7 French venous sheaths. The minimal diameter of the duct was 3.5 millimetres. The procedure, fluoroscopy, and hospitalisation times were 96.4 minutes (55 to 145), 13.1 minutes (3 to 25.2), and 24 hours, respectively. The "Nit-Occlud® PDA-R" was successfully deployed in all patients. Immediate, 24-hour, 1-, 3-, and 6-month closure rates were 65.5%, 79.3%, 96.5%, and 100%, respectively. The systolic pulmonary pressure diminished from 37 millimetres of mercury (21 to 57) before the intervention to 31 millimetres of mercury (21 to 45) after the intervention. No early or late embolisation, haemolysis, left pulmonary artery, or descending aorta obstruction occurred.. We conclude that the "Nit-Occlud® PDA-R" device is safe and effective in closing patent arterial duct up to a diameter of 8 millimetres.

Topics: Adolescent; Adult; Alloys; Bolivia; Cardiac Catheterization; Child; Child, Preschool; Chronic Disease; Ductus Arteriosus, Patent; Female; Fluoroscopy; Humans; Hypoxia; Infant; Male; Middle Aged; Prospective Studies; Prostheses and Implants; Treatment Outcome; Young Adult

Patent ducti arteriosi (PDAs) are more frequent and larger at high altitude than at sea level. A novel PDA closure device, the Nitocclud PDA-R, is designed specifically for both large and medium size PDAs. The initial clinical experience with a new nitinol-based device in high altitude patients with large PDAs is described.. The Nitocclud PDA-R is a self-expandable, self-centering, repositionable occluder made of one nitinol wire without use of welding. It contains several polyester membranes, is delivered with a central guide wire and is released by retraction of the central wire into the delivery catheter. The efficacy of this device was evaluated at several high altitude centers.. Fifty-one patients without other congenital cardiac defects underwent transcatheter closure of PDA. Complete occlusion of the PDA was achieved in 98% of the patients. Nearly 49% of the patients had no shunt immediately after device implantation. Echocardiography revealed a complete closure rate by Doppler interrogation of 69% after 24 hr, 96% after 6 months, and 98% after 1 year. In two cases, device embolization was observed after release, and in both cases the device was easily retrieved with standard interventional techniques. There have been no episodes of delayed device migration, endocarditis, hemolysis, wire fracture, device disruption, or death.. The Nitocclud PDA-R device is safe and effective and can easily close very large PDAs. This device has a high rate of complete occlusion within 1 year and is easily retrieved if embolized.

Topics: Adolescent; Adult; Alloys; Altitude; Argentina; Bolivia; Cardiac Catheterization; Child; Child, Preschool; Device Removal; Ductus Arteriosus, Patent; Echocardiography, Doppler, Color; Equipment Design; Female; Foreign-Body Migration; Hemodynamics; Humans; Infant; Male; Membranes, Artificial; Polyesters; Prospective Studies; Therapeutics; Time Factors; Young Adult

The recently released Amplatzer Ductal Occluder 2 (ADO2) was designed specifically for use in small children with moderate-sized shunts and larger children with small patent ductus arterioses (PDA). We report our initial experience with this device.. Patients referred with PDA underwent occlusion using the ADO2. This is a fabric-free nitinol wire 3-lobed device. All cases underwent pre-, intra- and post-procedural echocardiography, with follow up at 1 day and one month. Device sizing for device waist diameter and width was based on aortography.. Seven patients with a median age of 3 years and 4 months (range 7 months-23 years) and a median weight of 12 kg (range 7-56 kg) underwent successful PDA closure. The median ductal diameter was 1.5 mm (range 0.4-4 mm). Both transpulmonary (6/7) and transaortic approaches (1/7) were used. Recurrent patency at 24 hours with complete occlusion at 1 month was noted in a single case. A specific device-based length assessment applied resulted in shorter than recommended device selection.. The ADO2 broadens the spectrum of PDAs that can be simply and safely treated with devices. The flexibility of the articulations, coupled with the alternative deployment techniques, allow for increased ease of treatment in a range of small patients and specific ductal anatomies. An alternative device-specific length measurement of the duct length may result in less retaining disc protrusion. Broader experience is required to further delineate device and patient selection as well as to document its long-term efficacy and safety.

Topics: Alloys; Child; Child, Preschool; Ductus Arteriosus, Patent; Equipment Failure; Female; Follow-Up Studies; Humans; Infant; Infant, Newborn; Male; Postoperative Complications; Prosthesis Design; Prosthesis Fitting; Recurrence; Retreatment; Septal Occluder Device; Ultrasonography; Young Adult

An occluding device for closure of patent ductus arteriosus (PDA) was developed from meshed nitinol wires coated with platinum for prevention of nickel release after implantation.. Our purpose was to assess the immediate and short-term results of transcatheter PDA closure with this device.. Sixty patients (13 males and 47 females) underwent catheter-based PDA closure. The age ranged from 9 months to 65 years, with a median age of 4 years. The weight ranged from 4.2-65 kg, with a median of 15.2 kg. The mean PDA diameter at the narrowest segment was 4.7 +/- 2.2 mm, with a range of 2.0-15.1 mm. Eighteen cases had serial blood samples for serum nickel analysis taken before and at 1, 3 and 30 days after device implantation.. The devices were successfully deployed in all 60 patients. There were no serious procedural complications. Color Doppler demonstrated complete occlusion rate of 78.3%, 90.0% and 100% at 1 day, 1 month and 1 year after implantation, respectively. There was no statistical difference in serum nickel concentrations between pre- and post-implantation.. Transcatheter PDA closure using a platinum-coated nitinol device can be performed safely and successfully. There was no evidence of nickel release or nickel reaction after device implantation. This device model may be an alternative for PDA closure, especially in patients with potential nickel allergy.

Topics: Adolescent; Adult; Aged; Alloys; Catheterization; Child; Child, Preschool; Ductus Arteriosus, Patent; Equipment and Supplies; Equipment Design; Female; Follow-Up Studies; Humans; Infant; Male; Middle Aged; Nickel; Platinum; Retrospective Studies; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Surgical Procedures; Young Adult

Open surgical repair of patent ductus arteriosus is difficult in the case of elderly patients because of calcification of the duct and the possibility of rupture. Furthermore, endovascular repair with the use of a coil or an occluding device poses problems such as residual shunt or migration of the device. We describe a case wherein closure of a large patent ductus arteriosus in an adult patient was achieved using a Matsui-Kitamura curved nitinol stent-graft.

Topics: Alloys; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Ductus Arteriosus, Patent; Female; Hemodynamics; Humans; Middle Aged; Prosthesis Design; Stents; Tomography, X-Ray Computed; Treatment Outcome

Transcatheter closure is the preferred method of treatment of patent ductus arteriosus (PDA). Detachable coils are widely used to close small ducts, while the Amplatzer duct occluder (ADO) is generally employed for moderate or large ducts. Recently a new device, the Amplatzer duct occluder II (ADO II), a nitinol flexible mesh, with a symmetrical design to provide high conformability for treatment of all types of PDA, has received the European Community mark approval. We report on one of the first experience, four cases (1 male, 3 female, age ranging from six months to seven years old) with different type and size of PDA treated with the new device. The use of this new Amplatzer duct occluder in our experience has the advantage of ease and safety of placement, conformability, stability, low profile catheters, adaptability for long ducts as in type E.

Topics: Alloys; Cardiac Catheterization; Child; Child, Preschool; Coronary Angiography; Ductus Arteriosus, Patent; Equipment Design; Female; Humans; Infant; Male; Septal Occluder Device; Treatment Outcome

Topics: Alloys; Catheterization, Central Venous; Ductus Arteriosus, Patent; Female; Humans; Infant, Newborn; Infant, Premature; Male; Subclavian Vein

We report the first human implantation of an angulated plug in a 5 mm PDA in a child of 11 kg. Implanted through a 5 Fr sheath, the plug showed excellent anatomical alignment. Complete occlusion was documented after 6 hr. This device will extend the limits for interventional closure of PDA.

Topics: Alloys; Cardiac Catheterization; Ductus Arteriosus, Patent; Echocardiography, Doppler, Color; Embolization, Therapeutic; Equipment Design; Female; Humans; Infant

Transcatheter closure of the patent ductus arteriosus is a well established procedure. The objective of this study was to assess the effectiveness and the safety of the Amplatzer duct occluder.. Occlusion of the patent ductus arteriosus was attempted in 23 patients. The median weight was 11.7 Kg (range, 5 kg - 42.4 kg) with a mean ductus diameter of 3.7 mm (range, 1.6 - 7.2 mm). The immediate closure rate was 86% with a closure rate of 100% at 6 months, 1 year and 2 years following device placement. There was one device embolization that occurred immediately following device placement. No patient had aortic narrowing or pulmonary artery stenosis following the procedure.. The Amplatzer duct occluder is safe and effective in the closure of a patent ductus arteriosus up to 7.2 mm in diameter. Selecting a device at least 12 mm larger than the minimal ductal diameter can minimize embolization.

Topics: Alloys; Cardiac Catheterization; Child, Preschool; Ductus Arteriosus, Patent; Equipment Design; Follow-Up Studies; Humans; Infant; Prostheses and Implants; Stents; Time Factors

To evaluate whether transcatheter closure with the Amplatzer duct occluder offers an alternative to surgical treatment in infants with a persistent ductus arteriosus.. 12 patients under 1 year of age (age 1-11 months, body weight 2.6-8.7 kg) with clinical and echocardiographic findings of a significant duct were considered for transcatheter closure with the Amplatzer occluder. The device is made of a Nitinol and polyester fabric mesh and provides occlusion by stenting the duct. Measured angiographically, the narrowest diameter of the ducts ranged from 1.5-5 mm; in six patients pulmonary hypertension was also present.. The devices were implanted and complete duct occlusion was demonstrated during follow up in 10 patients. Procedure related difficulties occurred in nine of the 12 cases and led to relatively long procedure and fluoroscopy times (procedure time 50-180 minutes, median 80 minutes; fluoroscopy time 4.9-49 minutes, median 16 minutes). In two infants transcatheter closure could not be achieved and surgical duct ligation had to be carried out.. In small infants with a persistent ductus arteriosus the Amplatzer duct occluder offers an alternative to surgical treatment, but further improvement of the implantation system is necessary before the procedure can be recommended as the treatment of choice.

Topics: Alloys; Balloon Occlusion; Cardiac Catheterization; Ductus Arteriosus, Patent; Echocardiography, Doppler, Color; Humans; Infant; Infant, Newborn; Surgical Mesh

The aim of this study was to report further experience with transcatheter closure of the patent ductus arteriosus (PDA) using the Amplatzer duct occluder (ADO).. The design of previously used devices is not ideal for this purpose, and their use has been associated with several drawbacks, especially in large PDAs.. Forty-three patients, aged 0.3 to 33 years (mean 6.4+/-6.7 years), with a moderate to large, type A to E PDA, underwent attempted transcatheter closure using the ADO. The device is a plug-shaped repositionable occluder made of 0.004-in. nitinol wire mesh. It is delivered through a 5F to 6F long sheath. The mean PDA diameter (at the pulmonary end) was 3.9+/-1.2 mm (range 2.2 to 8 mm). All patients had color flow echocardiographic follow-up (6 to 24 months) at 24 h, 1 and 3 months after closure, and at 6-month intervals thereafter.. The mean ADO diameter was 6.1+/-1.4 mm (range 4 to 10 mm). Complete angiographic closure was seen in 40 of 43 patients (93%; 95% confidence interval [CI] 85.4% to 100%). The remaining three patients had a trivial angiographic shunt through the ADO. At 24 h, color flow mapping revealed no shunt in all patients. A 9F long sheath was required for repositioning of a misplaced 8-mm device into the pulmonary artery. The mean fluoroscopy time was 7.9+/-1.6 min (range 4.6 to 12 min). There were no complications. No obstruction of the descending aorta or the pulmonary artery branches was noted on Doppler follow-up studies. Neither thromboembolization nor hemolysis or device failure was encountered.. Transcatheter closure using the ADO is an effective and safe therapy for the majority of patients with patency of the arterial duct. Further studies are required to establish long-term results in a larger patient population.

Topics: Adolescent; Adult; Alloys; Aortography; Child; Child, Preschool; Ductus Arteriosus, Patent; Embolization, Therapeutic; Equipment Design; Female; Humans; Infant; Male; Retreatment

The aim of this study was to assess the immediate and short-term results of anterograde catheter closure of a moderate- to large-sized patent ductus arteriosus (PDA) using the new self-expandable, respositionable Amplatzer duct occluder (ADO) device.. Transcatheter closure of a PDA using devices or coils is technically challenging and may be accompanied by a 38% incidence of residual shunts.. Twenty-four patients (6 male, 18 female) underwent attempted transcatheter closure of a PDA using the ADO at a median age of 3.8 years (range 0.4 to 48) and a median weight of 15.5 kg (range 6 to 70). The mean PDA diameter at its narrowest segment was 3.7+/-1.5 mm. A 6F long sheath was used for delivery of the ADO. Follow-up evaluation was performed with color flow mapping of the main pulmonary artery within 24 h and at 1 and 3 months after closure.. Twenty three of the 24 patients had successful device placement. Angiography showed that 7 patients had complete immediate closure, 14 had a trace shunt (foaming through the device with no jet), and 2 had a small residual shunt (with a jet). Within 24 h, color Doppler revealed complete closure in all patients. The unsuccessful attempt was during an initial trial with a prototype that has been modified. The median fluoroscopy time was 13.5 min (range 6.3 to 47). All patients were discharged home the next day. There were no complications. Of the 23 patients, 21 completed the 1-month follow-up, all (95% confidence interval [CI] 86% to 100%) with complete closure, and 18 of 23 patients completed the 3-month follow-up, also all (95% CI 83% to 100%) with complete closure.. Anterograde transcatheter closure using the new ADO is an effective therapy for patients with a PDA diameter up to 6 mm. Further clinical trials are underway.

Topics: Alloys; Cardiac Catheterization; Child, Preschool; Ductus Arteriosus, Patent; Echocardiography, Doppler, Color; Female; Humans; Infant; Male; Prostheses and Implants; Radiography, Interventional