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Medtronic Awarded Emergency Authorization for Compact Ventilator to Support COVID-19 Patients

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April 16, 2020

Medtronic announced solid progress in the ramp-up of its ventilator production, as well as collaborating with technology partners and governments to drive new ventilator innovation and production, all in support of COVID-19 patients worldwide. On Wednesday, Medtronic announced it has received authorization from the U.S. Food and Drug Administration (FDA) to offer the PB560 ventilator in the U.S. through the agency’s Emergency Use Authorization (EUA) authority. This FDA decision allows Medtronic to provide another ventilator option to doctors and clinicians in the U.S. for patients with COVID-19.

PB560 Portable Ventilator Availability

The company expects the PB560 will be available in the U.S. in May. Introduced in 2010 and currently sold in 35 countries around the world, the PB560 is a compact, lightweight, and portable ventilator that can be used in clinical settings and at home. The PB560 ventilator average selling price is under $10,000 USD. The Puritan Bennett™ 560 ventilator may be mounted on a wheelchair or in a motor vehicle to support patient mobility.

Medtronic Ventilator Production Forecasts

The Medtronic ventilator portfolio primarily includes the PB980, PB840, PB560, and HT70 models. Today, across these platforms, Medtronic ships more than 300 ventilators per week to customers in the highest risk, highest need locations in the world. To aid specifically in the fight against COVID-19, Medtronic is prioritizing PB980 and PB560 production, which will generally be produced in similar volumes.

By the end of April, Medtronic expects to manufacture more than 400 ventilators per week. By the end of May, the company is expecting to manufacture more than 700 ventilators per week, and it is targeting more than 1,000 ventilators per week by the end of June, representing an approximately five-fold increase in production versus pre-pandemic levels. This Medtronic production ramp-up is expected to generate over 25,000 ventilators across all platforms over the next six months. The ventilator production increase does not include ventilators that will result from the company’s open-source initiative.

Medtronic Ventilator Open Source Initiative

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During the week of March 30, Medtronic started publicly sharing the design specifications for the PB560 to enable participants across the globe to evaluate options for rapid ventilator manufacturing at scale to help doctors and patients dealing with COVID-19. Since launch, there have been more than 90,000 registrations for the design specifications at Medtronic.com/openventilator. A range of entities are participating, from large scale manufacturers to innovative engineers and workgroups.

Medtronic has noted meaningful progress with three open-source manufacturers, including Baylis Medical Company, Inc. in Ontario, Canada, Foxconn Technology Group, a global manufacturer with operations around the world, and Vingroup Joint Stock Company in Hanoi, Vietnam. These manufacturers are working to advance Medtronic’s global priority – to increase ventilator production across the globe.

Puritan Bennett™ 980 Remote Access

Medtronic is currently in limited market release of a new remote management capability for its Puritan Bennett™ 980 (PB980) ventilator with two hospitals in the United States. This remote management capability – accelerated by collaborating with Intel Corporation – enables clinicians to adjust the ventilator settings outside of the Intensive Care Unit (ICU) and away from the patient, which may reduce healthcare worker and clinician exposure to patients recovering from COVID-19. If the feature is well received, the limited market release will be expanded to other U.S. customers later in April.

Source: HIT Consultant

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