Pathway Medical Technologies (Kirkland, Washington) President/CEO Tom Clement is on a mission to bolster the market for peripheral arterial disease (PAD) patients. More than 12 million people in the U.S. suffer from the disease, but of that number only 300,000 are getting the endovascular treatments that are needed, Clements said.

Commonly associated with high blood pressure, diabetes, heart disease, stroke and aging, PAD causes a buildup of plaque within the arteries that limits blood flow to the extremities. It can lead to severe limb pain, non-healing ulcers and critical limb ischemia, and if left untreated, can lead to gangrene, limb amputation and even death.

The most common intervention for PAD has historically included highly invasive procedures, including bypass surgery. Unfortunately, many patients are poor surgical candidates for whom such surgery can be life-threatening.

"There are an enormous amount of people who have complications from this disease," Clement told Medical Device Daily. "Some people don't get the treatment they need and this disease can lead to amputations and there are way too many of those. It's criminal."

Leg amputations often are viewed as a procedure of last resort for the most severe cases of PAD, and it is believed that more than 150,000 leg amputations are performed annually in the U.S. Not only is the number of procedures shockingly high, the prognosis for these amputees is horrible, only one-third achieving full mobility and, worse, up to 40% dying within two years of the initial amputation.

The answer to strengthening the market and cutting in on the amount of amputations in the country each year is simply through developing better PAD products, according to Clement, who left Boston Scientific (Natick, Massachusetts) in 1998 to found Pathway.

The company began cementing its path to developing more innovative PAD products nearly four years ago when it switched its focus from products targeting the heart to working in the lower extremities of the patient and with the recent FDA approval of its Jeststream peripheral artherectomy cathether, Pathway is poised at making good on this claim.

"Jetstream works a little like the way you use a shaver," Clement said. "Just like the whiskers can't get out of the way of the blade in the case of Jetstream, the plaque can't get out of the way either, but the artery walls much like the skin aren't damaged."

The device looks like nothing more than a drill bit at the end of a cable. Here's a more technical look at how the Jetstream works.

The catheter has an expandable cutting tip with rotating blades that safely debulks and preemptively removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions. Excised tissue and thrombus are continually aspirated from the peripheral treatment site through ports in the catheter tip to a collection bag located on the console.

The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure. According to the company, Active aspiration is a safety feature that minimizes the risk of distal embolization.

Jetstream boasts average device activation time of about 3-1/2 minutes during atherectomy treatment. For patients, Jetstream offers, according to Clement, "renewed hope" for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.

The device also delivers several cosmetic and user interface improvements from the company's first-generation product, the Pathway PV Atherectomy System, which was used in the Pathway PVD Study, a pivotal 172-patient European multi-center clinical trial. That study was carried out at three primary centers in Germany: Abteilung Angiologie (Bad Krozingen), Hamburg University Cardiovascular Center and Heart Center-University of Leipzig.

But even though the device has gotten off to a great start, the company faces fierce competiton from the now-merged ev3 Endovascular (Plymouth, Minnesota) and FoxHollow Technologies (Redwood City; California) via the Silver Hawk system, and from Spectranetics (Colorado Springs, Colorado), which has its PAD Excimer Laser Development system.

According to the Sage Group (Atlanta), a medical device market research consulting firm, several powerful market drivers - aging of the population, increasing PAD awareness, better diagnostics, improved therapeutics and earlier intervention are expected to nearly triple the size of the PAD space in the next few years, hopefully reducing the number of amputations (Medical Device Daily, July 24, 2006).

Pathway is hoping to ride the Jetstream into becoming a strong piece of this expanding market.