PFO Closure Device

The Septal Defect Closure Device is a highly adjustable device to ensure efficient closure of both ASDs and PFOs.

The Atrial Septal Defects (ASD) and Patent Foramen Ovale (PFO) closure device market has been identified as one of the most exciting areas for growth in the coming years by Millenium Research Group. With percutaneous device delivery now the first choice for treatment of ASD/PFO [surgery or life-long warfarin/aspirin therapy the other treatment options available] the healthcare market is awaiting a new generation of devices to emerge.

Successful closure of ASDs and PFOs via percutaneous delivery requires both complete coverage of the defect and apposition of the device to the septal wall to halt right-to-left shunt and paradoxical emboli. However, the symmetrical design of curre nt devices means that highly accurate positioning is required to achieve comprehensive closure of non-symmetrical septal defects. These current devices can also cause damage, due to their inability to conform  appropriately, to the adjacent septal wall upon deployment.

A well published and respected interventional cardiologist from a London NHS hospital Trust has designed a novel device for ASD/PFO occlusion. The design incorporates low-profile counter clamping elliptical 'envelopes' for the occlusion of septal defects. These elliptical envelopes can be rotated to occlude one or more defects and be rotated to avoid occlusion of the coronary sinus. A unique dual-core catheter delivery system allows independent rotation of the envelopes during deployment of the device. The construction of the envelopes is such that they will sit flush with the septal walls leading to superior occlusion of septal defects with a reduced chance of residual shunt compared with current closure devices. Other available devices are bulky and hence have thrombus formation and emboli issues whilst the additional material obviously has a knock-on effect on endothelialisation of the device. In paediatric ASD/PFO closure scenarios, a low profile conformable closure device a would offer a competitive advantage over the bulkier devices currently on the market.

Key Features and Benefits:

• Independent elliptical envelopes with eccentric connector/axis point - ensures wider coverage, allowing for a variety of septal defects to be closed
• Repositionable and retrievable prior to deployment - minimal damage to septum during deployment
• Low-profile elliptical envelopes - smaller delivery system needed; novel dual-core delivery catheter designed

Market Potential

Current devices on the market cost in the region of $3,000-$5,500. The US transcatheter embolization and occlusion market was valued at over $110 million in 2008¹. ASDs/PFOs have a potential role in causation of: stroke; platypnea-orthodeoxia; decompression sickness; right to left shunt; and migraine headaches. The most common form of Atrial Septal Defect (ASD), Patent Foramen Ovale (PFO), is present in 20-25% of the global population. ASDs account for 5% to 10% of all coronary heart disease, and for about 30% of the congenital heart defects diagnosed in adults. In April (2005), St. Jude Medical agreed to pay $82.5 million to acquire Velocimed, a four-year-old interventional cardiology company with three product platforms, one of which is a PFO closure device.

This product is currently available to license from NHSIL.

References:

1: Millenium Research Group: Global Markets for Heart Defect Closure Devices.