Airway secretions.

Not a pretty term, and especially not pleasant for the families and friends who have the job of clearing these secretions – okay, let's call them what they are, primarily mucus – of cystic fibrosis patients or others with the problems inherent in chronic pulmonary disease (COPD).

Cystic fibrosis patients normally require daily, half-hour, twice-a-day manual pounding of their chests, termed percussive therapy, to clear their lungs. The process is arduous, uncomfortable and technique-dependent, usually done in a head-down position by a skilled caregiver.

Addressing this issue in a non-manual, non-caregiver fashion are mechanical systems for doing this, and Electromed (New Prague, Minnesota) is about to release the third generation of its SmartVest Trimline Model Airway Clearance System, recently FDA 510(k)-cleared.

Requiring a prescription, the SmartVest is a personal, high-frequency chest wall oscillation (HFCWO) device that delivers this therapy, allowing the patient to do his or her own airway clearance and thus take greater charge in a self-care strategy.

“Another person . . . had to provide the percussive therapy, which was time-consuming, often inconsistently administered and sometimes painful for the patient,“ Robert Hansen, co-founder, CEO and chairman of Electromed, told Medical Device Daily. “The SmartVest uses automated chest and back compression, or HFCWO, to provide a gentler and more consistent treatment experience for the patient.“

Hence, he describes its major benefits as “independence from caregivers and consistency of treatment.“

An even bigger benefit is the device's steady life-saving ability and a key driver for uptake by providers as well as patients.

Hansen notes that in cystic fibrosis patients, or any others needing regular airway clearance, a large critical risk is pneumonia.

“The pooling or excess of secretions in the lungs really provides the environment in which the pneumonia bugs take off. But if you clear the lungs, the opportunity for the pneumonia bacilli to advance is really preempted,“ he says, citing a “basic but profound principle of cleanliness.“

And he points to figures indicating that pneumonia kills about 30% of people on a worldwide basis.

Hansen says that the “smart“ part of the SmartVest is in programming, with the ability to “remember“ up to three individual patient therapy prescriptions, assuring consistent therapy.

He acknowledges other such systems on the market but takes pains to differentiate the SmartVest as having a variety of patient-friendly and portable features.

The vest material is breathable fabric that he calls “nice and soft and pliable. It looks like a vest. The competition folks use plastic,“ which he says can result in general discomfort or itching. And it comes in a range of sizes, for children as young as 18 months, up to larger adults, with the comfort particularly important for the frail elderly.

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 situation. 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 fit into a two-wheeled case that can slide under an airplane seat or in an overhead bin for improved mobility. Hansen says that Electromed was the first to develop this system in portable form, its portability enhanced with rolling luggage carrier for travel.

The single-hose feature – as opposed to double hoses used by competitors – eliminates direct pounding on the sternum or abdomen. And this design distinguishes it as well on a legal basis, Hansen notes, referring to a patent infringement lawsuit against the company by Hill-Rom (Batesville, Indiana), with Electromed prevailing in a 2003 jury ruling.

Electromed says that HFCWO therapy has been prescribed for up to 200 diagnoses, Besides treatment of cystic fibrosis, SmartVest is used most frequently, it says, for bronchiectasis, COPD, asthma, advanced amyotrophic lateral sclerosis (Lou Gehrig's disease), multiple sclerosis, muscular dystrophy, cerebral palsy and for those whose movement is restricted due to accident or injury.

Electromed uses a Certificate of Medical Necessity/Rx that reduces paperwork for clinics and payers, acting as an advocate for the patient for both private insurance and governmental claims. And it says that Medicare reimburses most patients for the SmartVest when the diagnosis is cystic fibrosis or bronchiectasis and the condition is confirmed by a CT scan.

Privately funded, Electromed was founded by Hansen and his brother Craig in 1992, and it won initial 510(k) clearance for its first system in 2001. Holding more than 10 patents on the system, the company first concentrated on creating a portable system, reducing the weight to about 35 pounds, and the programmable mode was rolled out in 2005.

On cost: “Our strategy was to come into the market at 10% to 15% below competition,“ Hansen says, and that the company has had a steady growth rate of 40% each year, with 50% growth expected with its newest line in 2006.

The company said that this newest, third-generation SmartVest system would begin shipping next month.

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