Nearly a decade ago, a quartet of academic fellows at the University of Minnesota’s Earl E. Bakken Medical Devices Center came up with an idea for a permanently implantable medical balloon that could treat a deadly form of high blood pressure that often hits women in their 40s.
That idea took top honors recently in a contest for medical innovations held during a major medical device conference in San Diego. Aria CV, the St. Paul-based company that is spearheading the device’s development, could have a multibillion-dollar market niche on its hands if regulators one day approve it as safe and effective in treating forms of pulmonary hypertension, company executives believe.
“This is a tremendous unmet medical need. Pulmonary hypertension is a still a deadly, progressive disease, despite all the expensive prescription drugs” that can be used to treat it, said one of the device’s inventors at the U, John Scandurra. Scandurra is now president and CEO of Aria CV, which was formed to license the technology and then develop it into a full device.
Hypertension, also known as high blood pressure, is a common health problem in which blood pushes out too hard against the vessels. Pulmonary hypertension is a diverse group of conditions that share the common trait of causing too much pressure in the blood vessels between the heart and lungs, leading to other problems, including heart failure.
Aria CV is initially aiming to develop a device to treat the subset of patients whose disease is called pulmonary arterial hypertension (PAH), which affects women three times as often as men. Onset of PAH typically hits between ages 40 and 50, and survival “is on the order of six years or so. So it’s a really bad disease,” Scandurra said. It affects about 260,000 people in Europe and the U.S. today.
There are drug therapies for PAH — Scandurra said the drugs used to treat it already make up a $5 billion market — but typically those drugs work by changing the dilation of vessels in the lungs to reduce blood pressure backing up into the heart.
The Aria CV product uses a medical-device approach to change the blood pressure in the artery just outside the heart. That unique approach is why the device won the Shark Tank Innovation Competition that took place Sept. 22 at the Transcatheter Cardiovascular Therapeutics conference.
In a news release, Dr. Juan Granada, president and CEO of the TCT’s sponsor foundation, called it “a truly novel concept with potential to improve the survival and quality of life for people with heart disease.”
Normally the pulmonary artery is elastic, so that when the heart pushes out blood, the vessel expands to accommodate some of the force. The Aria CV device compensates for the loss of this elasticity.
The device includes a medical balloon permanently inserted into the pulmonary artery. When the heart pumps blood, the balloon collapses to bring down the pressure. Between beats, it reinflates, maintaining a more normal range of pressure in the artery and theoretically removing some of the extra workload on the heart.
The announcement of the award — which includes a $200,000 check — says that Aria CV’s “ingenious” device could also have application someday for a much larger group of patients in which pulmonary hypertension develops as a complication of congestive heart failure.
At TCT, Scandurra presented proof-of-concept data from a study in Vienna, Austria, examining how the device worked in 10 people who had stage 3 heart failure and pulmonary arterial hypertension. There were no adverse events during the procedures or during 30-day follow-ups. In a five-person subgroup selected by the treating physician, cardiac output increased 24 percent while exercising, the data show.
“Given that we are reducing workload on the heart, we believe that translates into [improved] survival,” Scandurra said. “Increasing cardiac output, or blood flow, delivers more oxygen to tissues, which increases exercise capacity and quality of life.”
That’s still a hypothesis as it relates to the effects of the Aria CV, and the device is likely years from potential approval from the FDA. But based on the data so far, the company is revving up for a larger clinical trial next year.
Aria CV has raised about $19 million from investors, including an undisclosed amount from an established medical device company with an innovative cardiovascular portfolio. Aria CV has kept its staff to seven people so far by relying on contractors in Minnesota and elsewhere handling various aspects of the engineering and manufacturing.
“We have maintained a small footprint and used a lot of contractors,” Scandurra said. “That is one thing about the Twin Cities — we do have a lot of access to cardiovascular expertise.”