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

News | Cardiovascular Clinical Studies

May 23, 2024 — A newly-published peer-reviewed study in the Journal of the American Heart Association, JAHA, found that ...

Home May 23, 2024
Home
News | Cardiovascular Clinical Studies

May 23, 2024 — Global Heart Hub, the international alliance of heart patient organizations, announced the first findings ...

Home May 23, 2024
Home
News | Cardiovascular Clinical Studies

May 21, 2024 — A new research paper was published in Aging (listed by MEDLINE/PubMed as "Aging (Albany NY)" and "Aging ...

Home May 21, 2024
Home
News | Cardiovascular Clinical Studies

May 20, 2024 — Cardiologist Brendan Carry, MD, and a team of Danville, PA-based Geisinger Medical Center physicians have ...

Home May 20, 2024
Home
News | Cardiovascular Clinical Studies

May 18, 2024 — Boston Scientific Corporation today announced positive six-month results from the ongoing pivotal MODULAR ...

Home May 18, 2024
Home
News | Cardiovascular Clinical Studies

May 17, 2024 — Royal Philips, a global leader in health technology, is presenting new retrospective study results ...

Home May 17, 2024
Home
News | Cardiovascular Clinical Studies

May 15, 2024 — A new study demonstrated parity between a minimally invasive procedure to replace the aortic valve in the ...

Home May 15, 2024
Home
News | Cardiovascular Clinical Studies

May 14, 2024 — One of the most common genetic heart diseases worldwide, hypertrophic cardiomyopathy (HCM) causes the ...

Home May 14, 2024
Home
News | Cardiovascular Clinical Studies

May 14, 2024 — An ambitious, nationwide clinical trial led by UVA Health’s Karen Johnston, MD, has provided doctors with ...

Home May 14, 2024
Home
Subscribe Now