A new tool designed to help physicians refine minimally invasive treatment of peripheral artery disease (PAD) could result in better outcomes for many of the 12 million Americans who suffer from an accumulation of plaque in arteries, which reduces blood flow.

Clearing out that plaque has, for years, been performed via angioplasty that makes use of a catheter to reach the blockage. Even though those catheters are considered flexible, they aren't always ideal for the curves of the human anatomy.

"Better manipulation of a catheter in the vasculature could result in better outcomes," Peter Altman, PhD, president/CEO, BioCardia (San Carlos, California) told Medical Device Daily. "It's been documented in literature that catheter manipulation sometimes dislodges plaque on artery walls and that causes embolizations downstream. In carotid stenting, 40% of strokes they cause are not in the target vessel. The process of accessing dislodges the plaque. By having a catheter platform that can be customized to the presenting anatomy, we are hopeful it will result in better outcomes."

Morph AccessPro has received FDA 510(k) clearance as a tool to refine this procedure. Surgeons currently use multiple preshaped catheters and scrape the soft curves up and down the aorta. The Morph AccessPro allows surgeons to use a single straight catheter. When they reach the target lesion, it deflects and takes on the needed shape in real time.

"It's a steerable introducer that gives a clinician the advantage of a deflectable catheter that can take the shape of any geometry," Altman said. "Because it can be shaped in the patient, it can have better back-up support than other catheters that are very soft and floppy at the distal end. It can provide for customization of the distal shape of the presenting anatomy.

"It was developed for lateral access procedures to be able to enter the femoral artery and cross up and over the bifurcation to a contralateral limb with a single device system as opposed to using multiple catheter exchanges," he said.

Atherosclerosis (hardening of the arteries) causes PAD. Being older, smoking, diabetes, high blood pressure, high cholesterol and obesity are some of the root causes. PAD causes pain and, left untreated, people are at risk for heart attacks, stroke and the loss of a limb.

While medication and lifestyle changes can help many people, those with moderate to severe blockages require angioplasty. The alternative for more difficult and hardened plaques is open surgery and, in some cases, limb amputation.

Altman said the Morph AccessPro may be the very first arterial access steerable conduit with a profile small enough to be used in routine PAD procedures. It has an inner lumen large enough to deliver the equipment needed to treat PAD such as stents, lasers and balloons.

"After an initial micro puncture of femoral artery, the physician advances a soft wire and then advances a shaped diagnostic guided catheter to gain control of lateral access," he said. "They have to manipulate the catheter and, in some cases, it can take a great deal of time or be impossible. Once up and over, they remove the soft wire and advance a stiff wire; then they remove the diagnostic catheter and advance a sheath platform. They remove the stiff wire and now they are ready for intervention."

Altman said the Morph AccessPro is "much quicker to navigate. The device is early in its life, but our hope is that it will replace other equipment that's used and save significant time."

He estimated the new tool could save 10 to 15 minutes.

"It carves out a new niche between guides and sheaths and has the benefits of both," Altman said.

At a cost of $475, it's in the same price range as other guided catheters, he said.

"We feel it will be a savings in the cath labs," he said. "Saving them from using multiple devices and saving time and enhancing outcomes with enhanced control and manipulation."

BioCardia manufactures the catheter in-house and the company is slowly ramping up its commercialization plan.

"We're seeing how the product does," Altman said. "Based on [feedback from] our sales force, we'll have discussion with other parties because a distribution deal would be attractive."