News | April 24, 2012

SeptRx Completes Enrollment for European Intrapocket PFO Occluder Trial

SeptRx IPO is designed to close hole in the heart defects and lower the risk of stroke, the second-leading cause of death worldwide

April 24, 2012 - SeptRx, an emerging medical device company that has developed the SeptRx Intrapocket PFO Occluder (IPO) — a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO) — reported that it has completed enrollment for its “InterSEPT” (In-tunnel SeptRx European PFO Trial) clinical trial in Europe, and has entered into a partnership with CoRRect Medical GmbH for commercial distribution in Germany and Switzerland of the SeptRx IPO.

The company intends that InterSEPT data will be used to apply for CE marking of the SeptRx IPO device in the second half of 2012, at which time commercial distribution will begin. The SeptRx IPO has previously completed a successful 11-patient first-in-human clinical trial, which demonstrated 100 percent closure and 100 percent safety out to three years.

“CoRRect Medical is committed to bringing innovative technologies to market,” said Michael Braun, general manager of CoRRect Medical. “The SeptRx IPO device is an elegant, next-generation medical device. We are extremely proud to be the first distributor to represent SeptRx’s breakthrough device in Europe.”

“We look forward to completing the InterSEPT trial in a successful and timely fashion. We are on schedule for applying for CE mark in the second half of this year,” said Scott Russell, SeptRx’s CEO. “Engaging an outstanding medical distribution partner such as CoRRect underscores our resolve to gain marketing approval of the SeptRx IPO device in Europe in the near term.”

PFO is a tunnel-like defect connecting the right atrium with the left atrium. A remnant of fetal circulation, it usually seals itself within a few months after birth. Unfortunately, in about 25 percent of the population the PFO does not fully close and may allow blood (and emboli) to pass directly between the right and left atria. The presence of a PFO has been identified as a contributing factor in cryptogenic stroke, chronic migraine, decompression sickness, and obstructive sleep apnea. A PFO contributes to these conditions by providing a pathway for emboli (blood clots, air bubbles) in the venous system to reach the arterial system by passing directly from the right atrium to the left.

The SeptRx IPO is not approved for sale in any regulatory jurisdiction. Further, it is not yet available for investigational use or commercial sale in the United States.

For more information: www.septrx.com

Related Content

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

News | Cardiovascular Clinical Studies | July 22, 2020
July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to re
The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp