Feature | July 20, 2010| Dave Fornell

Structural Heart Occluders in Development

NMT Medicals BioStar bioabsorbable occluder, several months after implantation.

PFMs Nit-Occlud for PDAs.

The Coherex FlatStent PFO occluder.

Occlutechs Figulla PFO occluder.

In addition to the FDA-cleared Gore Helex and the AGA Amplatzer transcatheter devices for atrial septal defects (ASDs), there are several others in development or already cleared for use outside the United States.

Produkte für die Medizin AG (PFM) currently offers the Nit-Occlud system in Europe. The spiral coil system is designed for transcatheter occlusion of patent ductus arteriosus (PDA) of all shapes. The company is now working on a patent foramen ovale (PFO) and ASD occluder, according to Ziyad Hijazi, M.D., MPH, professor of pediatric medicine, director of the Center for Congenital and Structural Heart Disease at Rush University Medical Center, Chicago. The company is also recruiting patients for a European trial using the Nit-Occlud to seal ventricular septal defects (VSDs).

NMT Medical’s CardioSeal and StarFlex are FDA-cleared to treat VSDs. The StarFlex is currently in U.S. trials to test its safety and efficacy in treating PFOs to prevent stroke/transient ischemic attack (TIA). The company also developed the bioabsorbable BioStar implant to seal atrial defects. It uses a set of self-centering microsprings and a collagen matrix. The collagen is absorbed by the body, only leaving behind the springs. The device is cleared for use in Canada and Europe.

The Coherex FlatStent has European approval to treat PFOs. The company has a distribution agreement with Abbott Vascular to distribute the device in Europe and Japan.

The Occlutech Figulla PFO and ASD occluder has clearance in Europe.

Hijazi said Gore is also working on a second-generation occluder device.

Related Content

coherex Wave Crest LAA Occluder

Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.

News | November 24, 2015
November 24, 2015 — Biosense Webster announced it has acquired Coherex Medical Inc., a privately held medical device
News | Heart Valve Repair| November 23, 2015
NaviGate Cardiac Structures Inc. (NCSI) announced that a first-in-human implant of its catheter-guided, mitral-valved...
Boston Scientific, Watchman FLX, LAA closure device, CE mark, first European implants

Image courtesy of Boston Scientific

News | Left Atrial Appendage (LAA) Occluders| November 20, 2015
Boston Scientific announced the first implants of the Watchman FLX left atrial appendage closure (LAAC) device
Sponsored Content | Videos | TCT| November 05, 2015
Tom Watson, clinical analyst for MDBuyLine, and DAIC Dave Fornell discuss some of the technology trends at the 2015 T
Sponsored Content | Videos | TCT| November 05, 2015
DAIC Editor Dave Fornell offers his choices for the most innovative new interventional cardiovascular technologies pr
aortic valve replacment, AVR, severe aortic stenosis, CURRENT AS registry, TCT 2015
News | Heart Valve Repair| October 27, 2015
A large observational registry found that initial aortic valve replacement (AVR) in asymptomatic patients with severe...
RESPECT trial, long-term study results, TCT 2015, PFO closure, recurrent cryptogenic stroke

Image courtesy of GE Healthcare

Feature | Stroke| October 16, 2015
Long-term study results from the RESPECT trial found that closing a patent foramen ovale (PFO) with an Amplatzer PFO...
Claret embolic protection, TAVR, cerebral protection

The Claret TAVR embolic protection system as seen in the aortic arch under angiography. The loops contain embolic filters they protect the ostium of vessles leading to the brain.

Feature | Heart Valve Repair| October 16, 2015
October 14, 2015 — Claret Medical, an innovator in cardiovascular cerebral protection, Data presented this week at Tr
News | Heart Valve Repair| October 15, 2015
Edwards Lifesciences Corp. announced that details on the 13 first-in-human compassionate use cases with its Forma...
PARTNER II Trial, TCT 2015, Edwards Lifesciences, Sapien 3 valve, one-year results

Image courtesy of Edwards Lifesciences

Feature | Heart Valve Repair| October 15, 2015
One-year patient outcomes from the PARTNER II trial showed the low rate of 30-day complications with balloon-expandable...
Overlay Init