Carag First-ever Septal Occluder With Bioresorbable, Metal-free Framework Available to Patients Through New European Registry

Baar, Switzerland and Berlin (ots/PRNewswire) - First 3-year-old patient
successfully implanted and discharged from hospital in Berlin

CARAG AG, a Swiss privately held medical device development company, announced
today the successful implantation of the first-ever transcatheter septal
occluder with bioresorbable, metal-free framework, as part of a new
international post-market registry. The study will grow the scientific body of
evidence on the use of the CE-marked Carag Bioresorbable Septal Occluder (CBSO),
which is designed to reduce complications and to improve patient options for
further cardiological interventions, in children and adults.

The CBSO was implanted in a 3-year-old patient with atrium septum defect (ASD)
at the German Heart Center Berlin by Professor Stephan Schubert, Senior
Cardiologist and Head of the Heart Catheterization Laboratory from the
Department of Congenital Heart Disease - Pediatric Cardiology. "The procedure
went very well, with excellent closure result and flat device profile. We are
excited to be able to offer this novel technology to our pediatric and adult
patients," stated Professor Schubert.

"Having a device without a metal framework has been a desire among physicians
since the beginning of transcatheter septal closure. Thanks to its resorbable
framework, the CBSO allows us to preserve all options for our patient in case we
need to perform a left-sided procedure in the future," confirmed Professor Felix
Berger, Director of the Department of Congenital Heart Disease - Pediatric
Cardiology at the German Heart Center Berlin.

Several other leading centers in Germany, Switzerland and in other European
countries will participate in the CBSO registry, which is aiming to enroll up to
100 patients. Carag is planning to initiate a clinical study for its CBSO in
trials centers in the United States under U.S. FDA Investigational Device
Exemption (IDE).

Transcatheter closure is the current standard of care for the treatment of
atrial septal defects and patent foramen ovale worldwide. Current implants
utilize a metal framework to support the occlusive material and to permanently
clamp the septum. The long-term presence of a significant amount of metal in the
heart leads to rare but serious complications such as erosion, arrhythmia and
thrombus formation. In addition, it forbids crossing of the septum to access the
left-side of the heart in following interventions, which significantly reduces
future treatment options for those patients.

"CBSO employs a device framework that disappears after fulfilling its primary
function following implantation," explained Jérôme Bernhard, Carag CEO. "This
may potentially reduce major device complications and enable future transseptal
access for these patients. The number of procedures requiring a transcatheter
approach to the left-side of the heart, such as mitral valve repairs and
replacements, left atrial appendage closure, or ablation is growing
exponentially. Therefore, CBSO addresses an important unmet clinical need by
preserving this access route and represents the first major advance in septal
occlusion technology in over a decade," he added.

Note: In the USA, CBSO has not currently received regulatory approval and it is
not available for commercial distribution.

About Carag

CARAG AG is a Swiss privately held medical device development company and an
innovation think-tank for the medtech industry. As a leading Swiss engineering
company, Carag is a point of contact for physicians and medtech companies
developing high-quality products for cutting-edge medical applications. Carag
has an experienced performance-driven, interdisciplinary team of engineers,
physicians, medical technicians, electronic technicians and software developers.
The company offers a broad range of services, from technical feasibility
assessments to product development and market approvals, regardless of the
regulatory complexity, in addition to developing own technologies and products.

www.carag.com/CBSO

Additional content: https://www.presseportal.de/pm/142103/4541959
OTS: CARAG AG

Original-Content von: CARAG AG, übermittelt durch news aktuell