Mallinckrodt Expands U.S. Rollout of INOmax® EVOLVE™ DS System

Mallinckrodt plc, a global specialty pharmaceutical company, has announced the launch of its next-generation INOmax EVOLVE DS delivery system in the United States. This new system, which has received clearance from the FDA, is designed for the administration of INOmax (nitric oxide) gas for inhalation. The launch follows the successful implementation of the INOmax EVOLVE DS Pilot program across several hospitals.

The INOmax EVOLVE DS is an advanced inhaled nitric oxide delivery system that integrates various components into a single cohesive device. These components include a primary delivery system, a monitoring system, an electronic blender, automated backup delivery systems, and mini-cylinders. The system aims to address the needs of neonatal intensive care unit (NICU) patients and healthcare providers by offering enhanced automation, which improves safety features and user experience.

INOmax is an FDA-approved treatment designed to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. It is used in conjunction with ventilatory support and other appropriate treatments. However, it is contraindicated in neonates dependent on right-to-left shunting of blood.

Lisa French, Executive Vice President & Chief Commercial Officer, expressed enthusiasm about the nationwide rollout of the INOmax EVOLVE DS. She highlighted the company's commitment to providing delivery systems with comprehensive safety features and noted the importance of continuing to work closely with customers to ensure the availability of the INOmax EVOLVE DS delivery system.

The INOmax EVOLVE DS delivery system boasts several notable features, including:
- Lightweight 4-lb mini-cylinders
- Automated pre-use checkout
- Pre-high-calibrated NO/NO2 gas sensor modules with automatic low calibration
- Automatic cylinder switching when empty
- An electronic blender that activates automatically with minimal oxygen flow detection
- Connectivity to electronic medical records, transferring over 100 data parameters
- A user-friendly touchscreen display

The comprehensive INOmax EVOLVE DS Pilot program allowed hospitals to thoroughly review the next-generation delivery system. Feedback from healthcare providers, including respiratory therapists, highlighted the system's ease of use and the benefits of its streamlined design and smaller cylinders.

With over 20 years on the market and more than 875,000 patients treated globally, INOmax has established a strong safety and efficacy profile. In 2023, the INOmax EVOLVE DS received the Human Factors and Ergonomics Society Stanley Caplan User-Centered Product Design Award, recognizing outstanding innovation and design.

The INOmax EVOLVE DS delivery system is now available for contracting and distribution to U.S. hospitals. The device is indicated for use in term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension for a maximum of 14 days.

Device warnings caution against the abrupt discontinuation of INOmax, which can lead to worsening oxygenation and increased pulmonary artery pressure. The system includes safeguards to ensure continuous delivery and proper setup, and it must be used with specified equipment to avoid malfunction.

Mallinckrodt is a global business that develops, manufactures, markets, and distributes specialty pharmaceutical products and therapies, focusing on areas such as autoimmune and rare diseases, immunotherapy, neonatal respiratory critical care, analgesics, and gastrointestinal products.