Custom Medical Devices

Transcatheter Patch Occlusion of an Ostium Primum ASD

admin — Fri, 24 Feb 2012 16:18:00 +0000

A 26 year male patient from Brazil had an ostium primum ASD operated in early childhood. The operation was unsuccessful and the large ostium primum ASD persisted without significant mitral insufficiency. Cardiac catheterization confirmed the diagnosis. The proximity of the ostium primum defect to the mitral valve make it inappropriate for wire device closure since the metallic structure of these devices can easily damage the valve. A 20 mm ostium primum ASD was measured by sizing balloon and occlusion was carried out using the Transcatheter Patch in conjunction with surgical adhesives (accelerated release). The procedure resulted in full occlusion of the defect and the patient was doing well on follow-up (5 years follow-up). Images show the ostium primum ASD before and 24 hours after occlusion.

Transcatheter Patch Closure of a Sinus Venosus ASD

admin — Fri, 24 Feb 2012 16:17:38 +0000

A 62 year old patient underwent surgery for atrial septal defect secundum 25 years ago. He had progressive symptoms of shortness of breath and heart failure. TEE echocardiography showed several small detachments of the surgical patch and a separate large sinus venosus ASD with normal pulmonary veins. He underwent transcatheter patch correction of the sinus venosus ASD with a small residual shunt and good follow-up. Two years later he underwent occlusion of some of the detached sutures using the ButtonSeal device. He is doing well 10 years after the sinus venosus ASD occlusion.

Immediate Release Patch Occlusion of a Sinus Venosus ASD (Part 3)

admin — Sat, 10 Sep 2011 07:40:03 +0000

This is the third part of a live case performed in 2011 at the CSI Congress in Frankfurt, Germany.

Immediate Release Patch Occlusion of a Sinus Venosus ASD (Part 2)

admin — Sat, 10 Sep 2011 00:03:32 +0000

This is the second part of a live case performed in 2011 at the CSI Congress in Frankfurt, Germany.

Immediate Release Patch Occlusion of a Sinus Venosus ASD (Part 1)

admin — Fri, 09 Sep 2011 23:21:12 +0000

This is the first part of a live case performed in 2011 at the CSI Congress in Frankfurt, Germany.

Immediate Release Patch LAA Occlusion

admin — Fri, 09 Sep 2011 20:22:30 +0000

Note: The Immediate Release Patch is only available for investigational use in this indication.

Investigating non-Secundum ASD Occlusion

admin — Sun, 03 Jul 2011 22:12:38 +0000

We are proud to announce the initiation of a clinical investigation to determine the safety and efficacy of non-secundum atrial septal defect (ASD) occlusion using the Immediate Release Patch (IRP).

Transcatheter occlusion has become the procedure of choice for the majority of secundum atrial septal defects, using a variety of devices. In contrast, non-secundum ASD correction is usually performed by surgery. Percutaneous correction of these defects may be preferable in certain instances, but the association of critical structures including partial anomalous pulmonary veins in sinus venosus ASDs or the proximity to the mitral valve in ostium primum ASDs makes commonly used devices inappropriate.

The Transcatheter Patch including its latest model, the Immediate Release Patch, has been used successfully for the occlusion of Non-Secundum ASDs including Sinus Venosus and Ostium Primum ASDs. The IRP is a wireless bio-absorbable device with a spherical shape and minimal rim requirements. Therefore, defects with deficient superior or inferior rims can be occluded without impinging on critical structures.

A video of a Sinus Venosus ASD occlusion performed live by professor Sievert can be seen in our Notable Case Reports section. If you are interested in participating in this clinical investigation please contact us.

IRP Occlusion of a Fontan Fenestration

admin — Sun, 06 Mar 2011 22:37:17 +0000

A 3 year old patient with fenestrated Fontan operation and aortic desaturation (84%). A wireless device was used, allowing for the possibility of re-opening if necessary in the future.

Immediate Release Patch Occlusion of a pVSD

admin — Thu, 22 Jul 2010 03:00:32 +0000

The patient was a 4 year old female born with a large peri-membranous ventricular septal defect (VSD). She had congestive heart failure and pulmonary hypertension in infancy, requiring pharmacologic treatment. The growth of the patient was slow. By the first year of life there was improvement of the patient’s growth rate and the heart failure, co-inciding with the development of an aneurysm of the membranous septum and some flow restriction. At 4 years of age there was still evidence of mild heart failure requiring medications. The decision for transcatheter occlusion of the VSD was taken by the patient’s parents since they preferred it to open heart surgery. Furthermore, they preferred a soft bio-absorbable occluder to a metallic occluder, because of the reported high incidence of complete heart block with such occluders.

Right and left heart caths were performed . Pressures and saturations were obtained. Qp:Qs was calculated at 1.6:1 and PA systolic pressure was 48 mmHg with a systemic of 98 mmHg. A left ventricular angiogram in a modified LAO view demonstrated a large peri-membranous VSD with a mouth of 12 mm and an aneurysm of the membranous septum. There were at least 2 large fenestrations through the aneurysm. The VSD was crossed by a R.coronary arterial catheter and an exchange wire was placed in the pulmonary artery. The wire was snared to the femoral vein. A 10 F Mullins catheter(Cook) was placed over the wire in the ascending aorta. A 5F pigtail catheter was placed at the level of the aortic valve.

A small Immediate Release Patch was chosen; it was advanced in the ascending aorta and it was inflated at the level of the aortic valve and the left ventricle. It was placed at the mouth of the defect and inside the aneurysm. Immediate full occlusion with a trivial shunt was confirmed by echocardiography. An LV angiogram confirmed the good result. The patch was detached and the bio-absorbable thread was sutured in the entry point of the groin.

The patient was discharged home the following day. One year follow up confirmed the good result and partial absorption of the patch.

Note: The Immediate Release Patch is only available for investigational use in this indication.

LAA Occlusion by Transcatheter Patch (ICE)

admin — Thu, 22 Jul 2010 02:51:42 +0000

Patient with atrial fibrillation and previous stroke after ablation. Occlusion of LAA was achieved by the Transcatheter Patch. Intracardiac Echo (ICE) was used for the first time in this procedure.

Note: The Transcatheter Patch is only available for investigational use in this indication.