Technology | August 30, 2013

FDA Clears PFM Medical’s Transcatheter Patent Ductus Arteriosus Occlusion Device

PFM Medical

August 30, 2013 — PFM Medical received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its Nit-Occlud Patent Ductus Arteriosus (PDA) device. Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter less than 4 mm.

A catheter containing the occluder is threaded into a vein in the groin and through the pulmonary artery. It is then advanced through the defect. When it is in the correct position, the coil is advanced through the catheter into the aorta. The coil wire is then released so that the last loop is on the pulmonary side of the defect.

The Nit-Occlud PDA device functions as a “plug” (occluder) to close an abnormal opening between the pulmonary artery and the aorta. The occluder is made of a self-expanding coil spiral that consists of an inner (core) wire tightly wrapped by an outer coil wire. After the device is in place, tissue will grow over it and the device then becomes part of the pulmonary artery.

This device can prevent blood from passing through the PDA, which may cause symptoms such as fatigue, difficult or rapid breathing, failure to grow normally, or chronic respiratory infections such as colds and pneumonia. Large openings can lead to heart failure and death. The device is implanted without the use of open-heart surgery.

A Phase II clinical study was conducted with 378 subjects enrolled in 15 study centers throughout the United States under an investigational device exemption (IDE) to establish a reasonable assurance of safety and effectiveness of the Nit-Occlud PDA. Favorable results meeting all objective performance criteria from this clinical study were the basis for the premarket approval decision.

For more information: www.pfmmedical.com

Related Content

News | Structural Heart Occluders

October 4, 2021 — U.S. Food and Drug Administration (FDA) has cleared the Abbott Amplatzer Talisman PFO Occlusion System ...

Home October 04, 2021
Home
Feature | Structural Heart Occluders | By Dave Fornell, Editor

September 20, 2021 — Abbott announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Portico ...

Home September 20, 2021
Home
News | Structural Heart Occluders

April 20, 2021 — Start-up medical device company atHeart Medical announced it is initiating its U.S. investigational ...

Home April 20, 2021
Home
Videos | Structural Heart Occluders

Interview with Carey Kimmelstiel, M.D., FACP, FACC, director, cardiac catheterization laboratory, director ...

Home March 24, 2020
Home
Technology | Structural Heart Occluders

June 10, 2019 – W. L. Gore & Associates (Gore) announced the U.S. Food and Drug Administration’s (FDA’s) premarket ...

Home June 10, 2019
Home
News | Structural Heart Occluders

March 27. 2019 — A newly released expert consensus statement provides recommendations for the safe and effective ...

Home March 27, 2019
Home
News | Structural Heart Occluders

February 13, 2019 — Le Bonheur Children's Hospital cardiologists in Memphis, Tenn., implanted the Amplatzer Piccolo ...

Home February 13, 2019
Home
News | Structural Heart Occluders

January 16, 2019 — Abbott announced the U.S. Food and Drug Administration (FDA) approved the Amplatzer Piccolo Occluder ...

Home January 16, 2019
Home
Videos | Structural Heart Occluders

Karen Orjuela, M.D., assistant professor of neurology at the University of Colorado Stroke and Brain Aneurysm Center ...

Home January 07, 2019
Home
Technology | Structural Heart Occluders

April 3, 2018 — Following the unprecedented Gore REDUCE Clinical Study conclusion that closure of patent foramen ovale ...

Home April 03, 2018
Home
Subscribe Now