Swiss medical device development company Carag has received the US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for its Carag Bioresorbable Septal Occluder (CBSO).
The CE-marked CBSO is a transcatheter septal occluder with a bioresorbable, metal-free framework.
The US clinical study for the device will enrol 250 patients in a staged study approach. The prospective, multi-centre study will evaluate the safety and efficacy of the CBSO in patients with clinically significant atrial septal defects (ASD).
Transcatheter implants with a metal framework, currently used for the treatment of ASD, are said to permanently clamp the septum.
The long-term presence of metal in the heart can cause severe complications, including erosion, arrhythmia and thrombus formation. In addition, such devices also limit the scope for future heart interventions, requiring septum crossing.
Carag CEO Jérôme Bernhard said: “We designed the CBSO to achieve a more natural intact septum by eliminating the metal framework, which has no purpose once the septum is healed.
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“Our novel approach enables pediatric and adult cardiologists to perform transcatheter septal occlusions today that will not undermine future left-sided interventional procedures, requiring transseptal access.”
The company expects to start the trial enrolment later this year.
Patients with ASD have an opening in the septum between the atria, allowing blood to return from the left to the right side of the heart. The excess of blood in the right ventricle and lungs can lead to enlargement of the right ventricle, shortness of breath, fatigue and palpitations.