D R Burton Healthcare Products LLC has Received 510(k) Clearance from the FDA for a Family of Innovative Oscillating Positive Expiratory Pressure (OPEP) Products

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D R Burton Healthcare Products LLC, makers of respiratory products and other medical devices, has received 510(k) clearance from the FDA for innovative oscillating positive expiratory pressure (OPEP) products. The D R Burton OPEP family includes the iPEP® system, an incentive Positive Expiratory Pressure system, which is the only metrics-based OPEP that measures lung volume.

D R Burton oPEP Family of Products

The D R Burton iPEP takes OPEP therapy from a blind technique to a data-driven therapy which measures patient inspiratory capacity.

D R Burton Healthcare Products LLC, makers of respiratory products and other medical devices, has received 510(k) clearance from the FDA for innovative oscillating positive expiratory pressure (OPEP) products. The D R Burton OPEP family includes the iPEP® system, an incentive Positive Expiratory Pressure system, which is the only metrics-based OPEP that measures lung volume. This family also includes a palm-sized PocketPEP®, a compact OPEP device for active patients, as well as the vPEP®, an easy-to-use OPEP device with excellent performance.

“FDA clearance of the D R Burton products represents a significant advancement in respiratory therapy, because the iPEP takes OPEP therapy from a blind technique to a data-driven therapy which measures patient inspiratory capacity,” says Dennis Cook, CEO of D R Burton and also a respiratory therapist. Cook adds, “For the first time, only with the iPEP, healthcare providers can now measure patient inspiratory capacity for exhalation effort during oscillating PEP therapy.”

Cook explains, "There is a need to prevent pneumonia in high risk patients, such as postoperative and patients with increased mucous production, which requires a simple improved clinical tool." He adds, “The low cost iPEP combines two standard of care therapies-- the inspiratory capacity measurement associated with an incentive spirometer along with the benefits of oscillating positive expiratory pressure (OPEP).”

Cook says, “This simple innovative iPEP device is designed to reduce the risk of not only hospital acquired pneumonia, but also reduce risk of pneumonia post discharge.” D R Burton provides a palm-sized OPEP module, the PocketPEP®, to transition from the hospital to the patient home for continued therapy post discharge. According to Cook, “it’s our goal at D R Burton to win the war on healthcare acquired pneumonia and respiratory-related readmissions.”

Following FDA clearance, the company plans to launch the product in the U.S., and is currently evaluating strategic partnerships to drive commercial availability.

About D R Burton Healthcare Products LLC
D R Burton Healthcare Products, a medical device innovator, was founded by physicians and healthcare clinicians with deep expertise in respiratory care. Together we design, develop and market medical device products that allow patients to heal faster and provide value to our partners and consumers. Our unique clinical perspective drives our unwavering commitment to provide clinicians and their patients with a world class user experience. For more information, please visit http://www.drburtonhpi.com

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