Medical Device Monday: Precision Flow HVNI

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Before we begin, let's take a deep breath! For many Americans, that simple task is not something to take for granted. Fortunately, Vapotherm’s respiratory device, Precision Flow® HVNI, helps neonate/infant, pediatric, and adult patients who are suffering from respiratory distress and/or hypoxemia, to enjoy the simple act of breathing.

Hypoxia is a lack of oxygen in the body— more specifically, a lack of oxygen in the tissue— that is usually brought on by hypoxemia, a low level of oxygen in the blood. Without oxygen, organs like your liver and brain can sustain damage and “suffocate” if oxygenation is not provided in a timely fashion. Hypoxia can be set off by a number of things like asthma attacks, lung diseases, anemia, and heart problems, and if no oxygenation is provided quickly enough, can lead to lung damage. While hypoxia can be lessened with things like inhalers or asthma medications, the Precision Flow is a new oxygenating device that aims to combat these symptoms with some savvy technology. Recently this device was granted a de novo classification by FDA as a High Flow Humidified Oxygen Delivery Device per 21 CFR 868.5454.

The device provides high velocity nasal insufflation (HVNI) with simultaneous oxygen delivery to augment breathing, and also adds heat and moisture to the breathing gases. The device uses an advanced high flow nasal cannula (HFNC) technique, which is commonly used to provide support for patients with respiratory distress. Interestingly, studies have shown that Precision Flow® HVNI can deliver gas in greater than three times the velocity of conventional humidifiers adapted for HFNC. According to the manufacturer, the HVNI technology functions similarly to the way a water hose would if a thumb was placed over the nozzle; the water (or in this case, gas) exits at a higher velocity. The device has a smaller cannula and a circuit design which helps the breathing gas to flow with higher velocity which, in turn, flushes out the dead space with greater efficiency than conventional humidifiers.

The warm, humidified gas also opens congested airways by helping to clear mucus. Moreover, it provides more comfort to patients when compared to the conventional non-invasive ventilation methods like Continuous Positive Airway Pressure (CPAP) or Nasal Intermittent Positive Pressure Ventilation (NIPPV) because of the small sizing of the cannula. Unlike the CPAP or NIPPV methods which use a mask for respiratory support, Precision Flow® HVNI uses small bore prongs which makes it easier for patients to carry out day-to-day activities like eating, drinking, and talking. In a recent multi-center randomized controlled trial,  treatment with Precision Flow® HVNI was found to be comparable to NIPPV for the treatment of adult patients experiencing undifferentiated respiratory failure in the Emergency Department. The Precision Flow helps clinicians to achieve the goal of delivering maximum respiratory assistance when it's needed the most. That's something we can all breathe a little easier about!


Additional Resources:

  1. How Precision Flow HVNI Works

  2. FDA de Novo Classification Order for Precision Flow

  3. Vapotherm Website