Advanced Respiratory Announces FDA Approval for The Vest

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The new Vest system Model 104 gives the same consistent, effective airway clearance therapy as earlier models and it's portable. Weighing only 17 pounds, it's half the weight and one-third the size of our previous device. It's also digitally automated and easy to use, making it a great choice for all of your patients with airway clearance needs. The new patient-friendly design will make it easier for your patients to be compliant with your orders, resulting in improved outcomes.

The Vest system has become part of the standard care regimen for patients with cystic fibrosis and is rapidly becoming the airway clearance therapy of choice for patients with cerebral palsy, muscular dystrophy, bronchiectasis, and COPD. In the last decade, more than 30,000 patients have used The Vest system to successfully manage their airway clearance needs, representing over 80,000 patient years of experience.

As a company, we have worked hard to earn your confidence and appreciate your support of The Vest system. And our commitment to you and your patients remains as strong as ever. Along with the introduction of the new Model 104, Advanced Respiratory will continue to offer immediate shipments, 30-day in-home trials, patient training, comprehensive reimbursement support, and a lifetime warranty.

We are excited about our newest model of The Vest system and the opportunity it affords patients and caregivers to benefit from effective airway clearance therapy. We trust you will also be delighted as you see the new device and hear the success stories from your patients.

Sincerely,

Elden H. Russell
President, Advanced Respiratory

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NEWS RELEASE
FOR IMMEDIATE RELEASE

FDA clears new medical device for nine million Americans with chronic lung disorders

Gentle Vest therapy replacing old “pounding” chest physical therapy in home

ST. PAUL, Minn., May 19, 2003 – Breathing comes naturally to everyone – but for millions of people, it does not come easily. For the nine million Americans fighting chronic lung disorders and diseases such as cystic fibrosis (CF), cerebral palsy (CP), muscular dystrophy (MD), and chronic obstructive pulmonary disease (COPD), Advanced Respiratory, Inc. today announces U.S. Food and Drug Administration clearance for The Vest™ airway clearance system Model 104. This small and powerful, but gentle medical device – employing high frequency chest wall oscillation (HFCWO) technology – is used in patients’ homes to replace manual chest physical therapy (CPT).

The Vest Airway Clearance System

When people catch the common cold, they usually become congested and have more difficulty breathing. Fortunately, the body is able to move the congestion, or excess mucus, out of the lungs by coughing so the individual can breathe easily again.

Breathing is not effortless, however, for those people whose disease creates more mucus than the body can remove naturally, or for those who have an impaired cough reflex. When mucus is trapped in the lungs, it creates an ideal breeding ground for infection. This causes the body to produce more mucus. The result is a cycle of recurrent episodes of respiratory inflammation, infection and, eventually, irreversible lung damage. To stop this cycle, those individuals require effective airway clearance therapy.

CPT – the repetitive, manual pounding on an individual’s back and chest – has traditionally been used to loosen secretions in the lungs. In fact, forms of CPT have been used to help manage airway clearance disorders since the early 1900s, and became widely recognized for CF patients in the 1960s. As a modern alternative, The Vest system is gradually replacing CPT as a gentler, painless in-home therapy. The Vest system also makes airway clearance therapy possible for patients who do not have access to CPT, or for whom CPT is not recommended.

Unlike CPT, The Vest system enables patients to receive airway clearance therapy without being dependent on parents or caregivers. Since The Vest system eliminates the need for pounding and positioning that is required with CPT, patients are also able to do other tasks while receiving therapy, such as nebulizer treatments, reading or working on the computer. Therapy with The Vest system is now standard care for patients with CF and is becoming recognized for CP, MD, bronchiectasis and COPD. It is reimbursed as medically necessary equipment by over 1,100 health plans and government programs across the country.

The Vest system is a medical device consisting of an inflatable vest attached to an air-pulse generator. Using HFCWO technology, the generator rapidly inflates and deflates the vest, compressing and releasing the chest wall 5-20 times per second to create airflow within the lungs. Its gentle pressure moves trapped mucus from the smaller airways in the lungs to the larger airways, where it can be removed through coughing or suctioning. The action also works to thin thick secretions, making them easier to clear.

The new model of The Vest system is smaller and more portable than the previous model. In fact, at 17 pounds, it is half the weight and one-third of the size – approximately the size of a portable audio system.

“Everyone knows that a person’s ability to breathe is vital. When breathing is impaired, it threatens your strength, your health, and in the worst case, your life," said Elden Russell, president and CEO of Advanced Respiratory. "With The Vest system, people are breathing easier. They have access to therapy that fits into their lifestyle, is easy to administer, and most importantly – improves their pulmonary health."

That could help millions of Americans breathe a little easier.

Advanced Respiratory Inc., headquartered in St. Paul, Minn., is the privately-held manufacturer and distributor of The Vest airway clearance system. For more information about the types of patients that could benefit from The Vest system, Advanced Respiratory and its products and services, visit the company’s Web site, http://www.thevest.com/.

For interviews, photographs, video or demonstrations of The Vest system, contact:
Kerstin March, Advanced Respiratory, 651.234.1633
Gwen Chynoweth, Maccabee Group, 612.337.0087