THE PRODUCT
Atrostim PNS — A treatment for congenital or acquired central hypoventilation
CENTRAL APNEA
Congenital or acquired central hypoventilation
Freeing patients from apnea without assisted ventilation
Atrostim PNS stimulates the phrenic nerve during sleep to restore a physiological breathing rhythm. Indicated in patients who have failed or cannot tolerate assisted ventilation — CCHS (Ondine's Curse), heart failure with central apnea (LVEF≤45%), refractory CSA.
SEVERE DISABILITY
High cervical spinal cord injury (C1–C3)
Phrenic stimulation as an alternative to mechanical ventilation
In tetraplegic patients with high cervical spinal cord injury, Atrostim PNS can replace mechanical ventilation by directly stimulating the phrenic nerves.
Proven technology, demonstrated efficacy
40 years of innovation, zero compromise — extensive scientific literature and international publications attesting to the long-term safety and clinical results of Atrostim PNS.
Available in many countries — France, Germany, England, Spain, Brazil
No implanted battery, no surgical revision
Quadripolar stimulation — no pain over 10 years
Zero phrenic nerve damage
Improved mobility and quality of life
Medical context
Phrenic nerve stimulation now recommended for Central Sleep Apnea
A major advance for thousands of patients with Central Sleep Apnea (CSA) who have failed or cannot tolerate positive pressure therapies.
In 2025, the AASM published updated clinical guidelines for CSA, incorporating phrenic nerve stimulation (PNS) as a recommended therapeutic option for primary CSA and heart failure-associated CSA.
AASM Recommendation (conditional): "The AASM suggests using phrenic nerve stimulation rather than no stimulation in adults with primary CSA and heart failure-associated CSA who have failed other therapies."
Badr MS et al. J Clin Sleep Med. 2025;21(12):2181–2191
Atrostim PNS est un système implanté de stimulation diaphragmatique basé sur la technologie propriétaire de Multipolar Sequential Stimulation (MSS). CSA is not a new indication: it falls within the framework of central hypoventilation acquise pour laquelle Atrostim est indiqué et remboursé en France depuis 2009.
source: HAS, 2015
Tidalium is the manufacturer and worldwide distributor of Atrostim PNS — in France and internationally. The group controls the entire value chain, from implant production and encapsulation mastery to market placement.
Implant manufacturing is handled by Atrotech Oy, a 100%-owned subsidiary based in Tampere (Finland), in ISO 6 & 7 and ISO 13485 certified cleanrooms. This vertical integration — rare in the AIMD sector — ensures total control over quality, timelines, and regulatory compliance.
Commercial distribution, logistics and after-sales service are managed from France. A new facility is under construction in the Hérault, which will house manufacturing and after-sales service for the external system components.
Distribution of Atrostim in France and worldwide. Logistics, after-sales service and support for healthcare institutions.
Production of Atrostim implants in ISO 6 & 7 cleanrooms. ISO 13485 and MDSAP certifications. Expertise in implantable electronics encapsulation, patented quadripolar electrodes, R&D and regulatory affairs.
Tidalium relies on a reference clinical committee and a strategic board covering the entire medical device lifecycle.
Over 30 years in medical devices. Co-founder of Medwin (sold to Vygon in 2014). Expert in industrial development, market access and reimbursement.
Over 20 years in healthcare. PhD in neuropharmacology. Supported Fabentech, Nanobiotix, HalioDx.
30+ years in AIMDs. Expert in quality, regulatory affairs and industrial management.
40+ years of leadership in medical devices. Dipl.-Ing. in electrical engineering.
National reference in thoracic surgery. Author of the landmark study on long-term use of Atrostim electrodes.
Member of Respifil (rare respiratory diseases). Expert in assisted ventilation and chronic respiratory diseases.
Founding of Atrotech — spin-off from the University of Tampere. Development of implantable phrenic stimulation.
First complete clinical implantations. Construction of the manufacturing facility in Tampere.
First CE marking of Atrostim (AIMD). Commercial launch in France.
HAS validation in France for congenital or acquired central hypoventilation, unilateral or bilateral — full Social Security reimbursement. New cleanroom in Tampere (ISO 6 & 7).
Acquisition of Atrotech by Sirmed — renamed Tidalium. Industrial and commercial structuring.
Development of the new Atrostim V2.5 neurostimulation platform.
MDR certification launched. New facility under construction in Hérault. Launch of the Atrostim CSA project.
Tidalium ensures manufacturing continuity of a selection of products from the historic Fourès range — low regulatory complexity medical devices for operating rooms, intensive care and resuscitation units. These activities, produced in France, complement our industrial offering and reflect our expertise in medical device manufacturing.