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

St. Jude Medical, ADO II AS trial, congenital heart disease, PDA, Amplatzer Duct Occluder II AS
News | Congenital Heart| October 19, 2016
St. Jude Medical Inc. announced the launch of the ADO II AS (AMPLATZER Duct Occluder II Additional Sizes) pediatric...
Cardioband, first tricuspid valve repair, University Hospital Zurich, Francesco Maisano
News | Heart Valve Technology| October 10, 2016
Francesco Maisano, clinic director at the University Hospital Zurich, recently led a team of cardiac surgeons and...
Northwestern Medicine, Edwards Lifesciences, Intuity Elite suturless aortic valve, first in Illinois

Edwards Intuity valve image courtesy of Northwestern Medicine

News | Heart Valve Technology| October 07, 2016
October 7, 2016 — A Northwestern Medicine cardiac surgeon was recently the first in Illinois and second in the United
Xeltis bioabsorbable valve implant, two-year data, EACTS 2016
News | Heart Valve Technology| October 06, 2016
October 6, 2016 — Xeltis announced this week that patients...
Xeltis bioabsorbable pulmonary heart valve, Xplore-I clinical feasibility study, first pediatric implants, EACTS 2016
News | Heart Valve Technology| October 04, 2016
October 4, 2016 — Xeltis recently announced that three pediatric patients have been successfully implanted with the w
Sponsored Content | Videos | Congenital Heart| October 04, 2016
Xeltis, a Swiss-Dutch clinical-stage medical device company, recently implanted three pediatric patients with the wor
Keystone Heart, TriGuard Embolic Protection Device, real-world results, PCR London Valves Conference 2016
News | Embolic Protection Devices| September 29, 2016
Keystone Heart Ltd. recently announced the safety and efficacy of the TriGuard Cerebral Embolic Protection device...
TCT 2016, TCT.16, main arena, late breaking trials
Feature | Cath Lab| September 28, 2016
September 28, 2016 — The Cardiovascular Research Foundation (CRF) has announced the 11 late-breaking trials and 16 fi
4Tech, TriCinch TTVR, transcather tricuspid valve repair device, first implant
News | Heart Valve Technology| September 22, 2016
4Tech Inc. announced that its TriCinch device has been used in the world’s first-ever successful transcatheter...
Overlay Init