When Boston surgeon Peter Bregman, MD, performs podiatric surgery on a patient, he attaches a small, microchip-controlled infusion pump to a thin tube that bathes the nerves of the patient's foot in anesthetic.

The patient stays awake during surgery and remains pain-free – though surgeries of the foot and ankle are quite sensitive and potentially extremely painful. After the surgery, the patient can go home, with the infusion pump attached to a belt pack. And most patients can remove the pump themselves while recuperating.

The product: the ambIT infusion pump from Sorenson Medical (Salt Lake City). The product and company have evolved from the fertile medical device pioneering work of James LeVoy Sorenson, perhaps challenging the entrepreneurial ingenuity – seen in the cardiovascular device arena – even that of legendary Thomas Fogarty, MD.

Sorenson Medical is just one of several endeavors that Sorenson has launched in the medical device field, this one focusing solely on an infusion pump platform, and forming the basis for a broad family of pump products.

"I try to use [the ambIT] on every patient" requiring surgery of the foot, Bregman told Medical Device Daily. Bregman is one of the early adopters of the pump, noting only surgery to the toes, the most delicate of all podiatry procedures, as the lone exception to his rule.

He notes that besides helping to eliminate the pain associated with foot surgeries, the ambIT pump avoids the need to use a general anesthetic, and its various complications, while also allowing the infusion of pain medication through the at-home continuum of treatment.

It is especially helpful, Bregman says, in what he calls a "triple-nerve release procedure" surgery that cuts ligaments pressing on the nerves and requiring three incisions and thus creating a variety of pain sources.

"I'm the only one in the state of Massachusetts doing this," Bregman says, and he testifies that the ambIT works "really, really well" for this type of procedure.

Additionally, he does surgeries on arthritic patients who need corrective surgery and on patients with bunions. "Nine out of 10 of my surgeries are completely pain-free now," he says.

"The local anesthetic we use with this new technique is like what your dentist uses, except instead of numbness for one-and-a-half hours, ours produces numbness for eight to 24 hours."

Pain medication is delivered by the ambIT directly to the surgical site or to a nerve "bundle," which connects the potential area of pain to the brain.

The pump's microchip technology enables the physician to program an exact medicine flow rate and duration appropriate to each patient's needs. The unit can then be placed on a belt – with power delivered by two AA batteries – so the patient can maintain pain relief at home. The patient also can deliver an additional bolus of medication, but with a fail-safe system built into the device preventing these additional infusions from being delivered more frequently than the physician-specified intervals.

Most patients can then remove the medication delivery catheter themselves, in two to three days after the procedure, rather than needing to come back to his office for its removal, Bregman says.

Training the patient to use the device, he says, is relatively simple, with future generations of the ambIT to be even simpler, via a single-button control.

The pump was FDA-cleared in 2000, according to Tom Orsini, president and chief operating officer of Sorenson Medical, with a "limited" marketing rollout in 2001 and additional pump products then developed by the company.

He says the company has recently put together its own direct sales force in the U.S., and that Europe has become "a strong market; and we're expanding our presence throughout the Asia Pacific."

Sorenson Medical also developed a suction catheter system that was divested to Abbott so that the company could place its full emphasis on commercializing its pumps.

"We have one company focus," Orsini told MDD, "so that we have more clarity of thought. When you walk in, you know what we're about."

For now – and with that focus – "we will go it alone," Orsini says, but he won't say "never" to the possibility of a buyout exit or initial public offering. "We think this company has tremendous growth potential. We want to see where we can take it. But who knows what the future will hold?"

Orsini notes that Sorenson Medical is just one of a portfolio of ventures that James LeVoy Sorenson oversees as board chairman and as head of Sorenson Development Inc., with his son, James Lee Sorenson, serving as CEO of Sorenson Medical.

That broad portfolio, Orsini notes, ranges from other medical device firms to large real estate holdings to media to "the largest cattle ranch in Utah."

In 1972, Sorenson founded Sorenson Research to manufacture his medical device innovations, and he then in 1980 sold that firm to Abbott Laboratories (Abbott Park, Illinois), which renamed it Abbott Critical Care Systems.

His improvements in patient care include the world's first disposable surgical filter masks, as well as disposable venous catheters which eliminated the use of metal needles. He also developed catheter systems for monitoring conditions inside the heart and systems for recycling blood in the operating room.

Besides his work in medical devices – and a portfolio of more than 50 patents in that sector – Sorenson also has founded a group of companies focused on DNA testing and the development of genetic records.

The Sorenson Medical web site says that the non-profit Sorenson Molecular Foundation (profiled by MDD in our April 5 edition) will be his ultimate legacy and that by "compiling world genealogy information and connecting it to DNA analysis, the foundation intends to create a huge database of human heredity."

The ultimate goal: "to find a [global] brotherhood" so that "once people understand how closely related they are, the more motivated they will be to treat each other well."