Capnopharm’s new CapnoPen CP-001k has received CE certification (MDR) for aerosolizing chemotherapy, DNA, RNA, nanomolecules, viruses, and immunotherapy into body cavities. As the only nebulizer with such certification, the new CapnoPen is setting a new regulatory standard in Intraperitoneal Chemotherapy.
Stéphane Rohan Laurent, Capnopharm’s VP Sales & Business Development, commented: “Receiving CE certification constitutes a landmark achievement for our new CapnoPen technology. It also responds to the growing demand from the oncology community for durable, harmonized standards in Intraperitoneal Chemotherapy.”
Capnopharm’s new CapnoPen is the first PIPAC nebulizer to obtain CE marking under the new MDR regulation 2017/745.
Prof. Marc Reymond, Capnopharm’s CEO, said: “Capnopharm’s new Capnopen is approved for its effective intended use, namely aerosolizing chemotherapy, DNA, RNA, nanomolecules, viruses, and immunotherapy into body cavities. This is in contrast to other nebulizers on the market which are only approved for aerosolizing aqueous solutions or for irrigating the abdominal cavity: in clinical practice, these nebulizers are used “off-label”. The new Capnopen is now classified into the appropriate risk category. Its regulatory approval meets the most current MDR standards and is the result of a thorough technical, biological, and clinical evaluation. This evaluation and the resulting approval protect the interests of patients and healthcare practitioners alike”.
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