Studies at pfm

 

National and International Studies at pfm medical.

 

As a company involved in research and development, pfm medical conducts national and international clinical studies.

In addition to studies examining safety and effectiveness (pre-approval studies), pfm medical also conducts market observation studies. The purpose of these is proving patient benefit as well as the scientific investigation of rare side effects and the long-term effectiveness of our products.

We Promote Transparency –

pfm medical publishes all the results from its studies. Only the transparent and complete publication of study results ensures their full benefit to medical research, their contribution to progress and their advantage to patients.

pfm medical places great value to the neutral presentation and evaluation of the results of these studies. In order to meet these requirements, we commission reputable research institutes and work with independent scientists and experts.

Strict Requirements – From Design to Publication –

International scientific research is regulated by numerous criteria that clinical studies have to comply with. Studies must adhere to a high degree of safety and fulfil certain conditions. Ethical questions are also of importance; for each study, these questions have to be examined by an accredited ethics commission. Pre-approval studies must also be examined by the relevant state regulatory authorities.

Completed and Current Studies –

Studies with completed recruitment currently in the evaluation stage:

  • Procedural success and safety of the Nit-Occlud® patent foramen ovale (PFO) closure device and its application system
  • Pre-market approval application: Nit-Occlud® spiral coil for PDA occlusion

Current Studies:

National, Multicenter PMS Study “Patient Reported Outcome” in Breast Reconstruction Following Mastectomy With TiLOOP® Bra (PRO-BRA)

Quality of Life after tension free transvaginal sling/tape Operation with a Titanized Surgical Tape (TiLOOP® Tape)

Safety and effectiveness of the Nit-Occlud® Lê VSD spiral coil system

Anterior pelvic prolapse reconstruction with TiLOOP® Total 6