SeptRx has concluded enrolment of the first 20 patients in its ongoing InterSEPT clinical trial at Sankt Katharinen Hospital in Frankfurt, Germany.
The prospective multicentre single-arm InterSEPT trial will evaluate the safety and efficacy of the SeptRx Intrapocket PFO Occluder as a treatment for percutaneous transcatheter closure of a heart defect known as patent foramen ovale
The findings from the InterSEPT trial will be used to apply for European approval for the SeptRx Intrapocket PFO Occluder, which is designed to close "hole in the heart" defects and lower the risk of stroke.
In a previous successful 11-patient first-in-human clinical trial, the SeptRx Intrapocket PFO Occluder demonstrated 100% closure and 100% safety following three years of treatment.
SeptRx CEO Scott Russell said earlier excellent patient outcomes from the first-in-human study will support the expansion of the trial into additional centres and the introduction of a larger 19mm device into the trial.
In June 2011, the company received $2.7m in Series A financing from Nitinol Devices & Components, to advance SeptRx IPO through CE mark registration.
The SeptRx Intrapocket PFO Occluder is not approved for sale in any regulatory jurisdiction, and it is not yet available for investigational use or commercial sale in the US.