Healthcare Industry News:  amyotrophic lateral sclerosis 

Devices FDA

 News Release - February 15, 2006

Electromed Inc. Announces New SmartVest Trimline Model Airway Clearance System, Receives FDA 510(k) Clearance

Self-Directed HFCWO Therapy Clears Lungs to Reduce the Risk of Pneumonia

An Attractive Option for Patients with Cystic Fibrosis, Bronchiectasis, Obstructive Pulmonary Conditions and Other Diseases Presenting Excess Secretions

NEW PRAGUE, Minn.--(HSMN NewsFeed)--Feb. 15, 2006-- Most people do not think about taking their next breath; it happens as easily and naturally as blinking an eye. But for individuals with cystic fibrosis, bronchiectasis, chronic obstructive pulmonary conditions, or diseases such as multiple sclerosis and muscular dystrophy, the ability to breathe is a life and death matter.

Now, individuals with airway clearance challenges have a new life-enhancing, state-of-the-art option for reducing airway secretions, priced to provide superior value. Electromed, a Minnesota company dedicated to developing innovative medical products for people with airway clearance problems, has introduced its next-generation SmartVest® Trimline Model Airway Clearance System. The company also said that it had recently received FDA 510(k) clearance to market the new Trimline model. The new system and the therapy it provides must be prescribed by a physician.

Effective therapy with a gentle touch - anytime, anywhere

The SmartVest is a personal high frequency chest wall oscillation device that enables patients to take charge of their own therapy, without help from family or other caregivers. For many years, those with pulmonary diseases - like cystic fibrosis - relied on others to provide manual chest percussive therapy daily to clear their lungs.

"Another person - like a parent, friend, other relative or caregiver - had to provide the percussive therapy, which was time-consuming, often inconsistently administered and sometimes painful for the patient," said Electromed co-founder, Chairman and CEO, Robert D. Hansen. "The SmartVest uses automated chest and back compression, or HFCWO, to provide a gentler and more consistent treatment experience for the patient - no outside help needed. The independence from caregivers and consistency of treatment, which the SmartVest provides, are the major benefits."

Consistency, ease of use, portability and mobility

The SmartVest is aptly named. It is able to "remember" up to three individual patient therapy prescriptions, assuring consistent therapy day after day. The vest comes in a wide range of sizes for children as young as 18 months as well as larger adults. It has a single removable hose that connects the vest to a compact, portable generator, which operates in horizontal or vertical positions for use in nearly any home or lodging environment. The generator and hose provide an air pulse flow to the vest that delivers oscillation to clear the airways and improve bronchial drainage. The vest, generator and hose all fit neatly into a two-wheeled case sized to go under an airplane seat or in an overhead bin, vastly improving patient mobility and quality of life.

"The SmartVest is made of soft, breathable fabric that is machine washable," explained Hansen. "Users tell us that it is more comfortable than stiff, plasticized vests, which can result in greater perspiration and itching." The therapy is more comfortable as well. The SmartVest's Soft Start(TM) feature eliminates abrupt start up. And, because of its single hose and a bottom-up air fill feature, the SmartVest does not creep up or become bulky. Patients can move about and multi-task while receiving their therapy."

Fostering improved lung condition; providing superior value and user benefits

The SmartVest's unique airway clearance system offers those with cystic fibrosis an attractive alternative to manual chest percussion - but cystic fibrosis sufferers are not the only ones who benefit from HFCWO. Physicians prescribe this treatment modality for other individuals with pulmonary problems, including patients with bronchiectasis, chronic obstructive pulmonary disease, asthma, advanced amyotrophic lateral sclerosis (Lou Gehrig's disease), multiple sclerosis, muscular dystrophy, cerebral palsy, and those whose movement is very restricted due to accident or injury.

Electromed's strategy is to offer its life-improving technology available at a superior value. Therefore, the cost of the SmartVest includes: the generator and carrying case, respiratory therapist or nurse-supported patient training, and lifetime and technology advancement warranties. Electromed utilizes a Certificate of Medical Necessity/Rx that reduces paperwork for clinics and payers, and secures reimbursement for patients through its own reimbursement department. The company's reimbursement department carefully reviews patient payor alternatives and acts as an advocate for the patient for both private insurance and governmental claims. Medicare reimburses most patients for the SmartVest when the diagnosis is cystic fibrosis or bronchiectasis and the condition is confirmed by a CT scan.

"The SmartVest is easy to use, effective and well-tolerated by even the youngest of patients - as well as older, fragile users," said Hansen. "The word is spreading quickly: This innovative therapy has reduced health care costs by helping patients avoid recurrent pneumonia, as well as hospitalizations for other pulmonary infections. SmartVest is the smart choice."

The SmartVest Trimline Model ships in April 2006. Patients who select the SmartVest prior to that time will receive the current Model 2000ez Airway Clearance System, which can later be exchanged for the newest system at no additional charge to the patient.

About Electromed: "Creating superior care through innovation.(TM)"

Electromed Inc., is a privately held company that makes proprietary airway clearance products. Founded by brothers Robert D. Hansen and Craig N. Hansen in 1992, Electromed develops, manufactures and markets the SmartVest Airway Clearance Systems for both home and institutional use in the United States and abroad. It was the first in its industry to offer portable and programmable systems. The company holds more than 10 patents on its SmartVest clearance airway systems. For more information about Electromed and SmartVest Systems, visit or call 1-800-462-1045.

Source: Electromed

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