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

Appropriate Use Criteria Published for Valvular Heart Disease Imaging Tests
News | Clinical Decision Support| October 16, 2017
The American College of Cardiology (ACC), along with several partnering societies, recently released appropriate use...
Medtronic Announces Post-Market Study for CoreValve Evolut Pro System
News | Heart Valve Technology| October 02, 2017
Medtronic plc recently announced a new post-market clinical study to evaluate its CoreValve Evolut Pro valve in...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
TCT 2017 late-breaking trials and studies that will be presented on the latest cardiology technology clinical trials.
Feature | September 11, 2017
September 11, 2017 — From numerous high-quality submissions, Transcatheter Cardiovascular Therapeutics (TCT) has sele
LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

Feature | Left Atrial Appendage (LAA) Occluders| September 07, 2017
September 7, 2017 — Closure of the left atrial appendage (LAA) during heart surgery protects the brain, according to
Protembis Announces Successful First-in-Human Use of  ProtEmbo Cerebral Protection System in European Trial
News | Embolic Protection Devices| September 07, 2017
Protembis GmbH announced the first clinical applications of its ProtEmbo Cerebral Protection System to complement a...
Siemens Healthineers Receives FDA Clearance for TrueFusion Structural Heart Disease Feature
Technology | Cardiovascular Ultrasound| September 06, 2017
The U.S. Food and Drug Administration (FDA) has cleared TrueFusion, a new cardiovascular application from Siemens...
Minneapolis Heart Institute Foundation Enrolls First Patient in TRILUMINATE Tricuspid Repair Trial
News | Heart Valve Technology| September 05, 2017
Minneapolis Heart Institute Foundation announced it has enrolled the first-in-the-world patient in a clinical study to...
Overlay Init