pfm medical receives FDA Premarket Approval (PMA) for Nit-Occlud® PDA, Transcatheter Patent Ductus Arteriosus (PDA) Occlusion Device

Köln, (PresseBox) - pfm medical, a leading developer and manufacturer of innovative, minimally invasive medical devices for cardio vascular technology, vascular access, surgery, and oncology, has received U.S. Food and Drug Administration (FDA) premarket approval for its Nit-Occlud® PDA device on 22th August 2013. 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 Phase II Clinical Study was conducted with 378 subjects enrolled in 15 study centers throughout the U.S. 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.

Aurel Schoeller, CEO of the pfm medical group, is pleased with the successful product introduction: „Nit-Occlud® PDA is one of our main innovative products. Its FDA approval for us represents a key step towards achieving market share in the US“, he said.

Website Promotion

pfm medical ag

Founded in 1971, pfm medical is a privately-owned, globally active, independent manufacturer, technology partner, service provider, and distributor headquartered in Cologne, Germany with offices and subsidiaries worldwide.

Press releases you might also be interested in

Weitere Informationen zum Thema "Medizintechnik":

Unternehmen setzen auf KI und Maschine Learning

Ei­ne von So­phos un­ter­stüt­ze ak­tu­el­le IDC-Stu­die zeigt auf, dass 70 Pro­zent der Un­ter­neh­men pla­nen, die­ses Jahr Künst­li­che In­tel­li­genz und Ma­chi­ne Lear­ning (ML) ein­zu­set­zen, um die IT-Si­cher­heit zu ver­bes­sern. Für die IDC-Stu­die wur­den im letz­ten Quar­tal 108 Un­ter­neh­men mit mehr als 1.000 Mit­ar­bei­tern be­fragt.

Weiterlesen

Subscribe for news

The subscribtion service of the PresseBox informs you about press information of a certain topic by your choice at a choosen time. Please enter your email address to receive the email with the press releases.

An error occurred!

Thank you! You will receive a confirmation email within a few minutes.


I want to subscribe to the gratis press mail and have read and accepted the conditions.