German medical equipment manufacturer PARI Pharma has issued the CE declaration of conformity for its optimised eFlow Technology LAMIRA Nebuliser System.

The LAMIRA Nebuliser System is specifically optimised for the administration of ARIKAYCE using patented features.

eFlow technology is an aerosol delivery platform, designed for nebulisation of liquid medications through a vibrating, perforated membrane.

The technology improves the upper and lower respiratory tract deposition and reduces the burden of severe respiratory conditions treatment, said the company.

PARI’s CE declaration of conformity is in line with the medical devices directive for LAMIRA, while Insmed secured the EC marketing authorisation for ARIKAYCE on 28 October.

PARI Pharma eFlow development and operations vice president Stefan Seemann said: “LAMIRA is another great example of a nebuliser derived from our eFlow Technology platform and tailored for a specific medicinal product.

“We leveraged our laser drilled membrane technology and patented aerosol chamber to optimise the delivery of ARIKAYCE’s unique liposomal formulation for the benefit of patients with a high need for therapies.”

LAMIRA system will administer ARIKAYCE Liposomal 590mg to treat MAC

The optimised eFlow Technology LAMIRA system is designed for administration of ARIKAYCE Liposomal 590mg nebuliser dispersion.

ARIKAYCE is the first EC approved inhaled liposomal dispersion and the first and only therapy indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections due to Mycobacterium avium complex (MAC) in the EU.

MAC lung disease is a rare and serious disorder, capable of increasing morbidity and mortality. The patients experience symptoms including chronic cough, dyspnoea, fatigue, fever, weight loss, and chest pain, which often worsen over time.

The company claimed that its LAMIRA Nebuliser System is the sixth drug-specific eFlow technology device to become commercially available.

PARI Pharma president Martin Knoch said: “Following the approval of ARIKAYCE and LAMIRA by the US FDA in 2018, we are pleased to expand our partnership with Insmed and to have the opportunity to make the first approved treatment available for these seriously ill patients in Europe.”

Insmed Europe, Middle East and Africa head Neil Hughes said: “LAMIRA is integral to delivering ARIKAYCE to appropriate patients with MAC lung disease. We are very pleased about this achievement with our capable and reliable partner PARI.”