SAN DIEGO — A novel device to treat pulmonary hypertension won the Shark Tank Innovation Competition held at TCT 2018.
The device, developed by Aria CV Inc. of St. Paul, Minnesota, was designed for patients with various forms of pulmonary hypertension, said John Scandurra, DVM, co-founder and CEO of the company.
“Even with the current standard of care of drug therapy, this is still a progressive, deadly disease, with median survival ranging from 3 to 7 years depending on etiology,” Scandurra told Cardiology Today’s Intervention. “Our initial target is to address pulmonary arterial hypertension, but there are other forms, such as pulmonary hypertension due to left heart disease or due to lung disease, which are of greater prevalence and might be future indications.”
The company was one of seven selected from more than 30 applications to present to a panel of “sharks” at the conference. The panelists rated the devices based on unmet clinical need, out-of-the-box concept, intellectual property position and viability, biological proof of concept, regulatory pathway and commercialization potential.
For the first time in the competition’s history, the Jon DeHaan Foundation donated $200,000 to the Cardiovascular Research Foundation to give to the winning company to help fund its technology’s development.
Scandurra said during his presentation that the device was designed to address increased stiffness of pulmonary vessels caused by elastin breakdown and collagen deposition. The excessive stiffness and increased resistance to blood flow lead to elevated afterload on the right ventricle, which in turn leads to right HF and, eventually, death.
“The resistance component is the historical underpinning of pulmonary hypertension and the target of drug therapy,” Scandurra told Cardiology Today’s Intervention. “But it is becoming better understood that vascular stiffening precedes the change in resistance in these patients. Aria’s device provides a therapy that addresses the effects of this stiffening by replacing some of the compliance lost within the vasculature and reducing the workload on the right ventricle.”
The device has a gas-filled reservoir connected to a gas-filled balloon via a conduit and does not contain any batteries or electronics. Similar to a pacemaker, the reservoir is implanted percutaneously, the conduit enters the axiliary vein and the balloon functions in the main pulmonary artery, Scandurra said.
“The simplest way to understand how the device works is to focus on how it alters pressure in the pulmonary artery,” he said during the presentation. “By lowering RV afterload, we believe Aria’s device has beneficial effects on the entire pathologic cascade of right heart failure.”
In a first-in-human study of 10 patients, the device was associated with a 9% increase in cardiac output during rest and a 24% increase in cardiac output during exercise.
“The device is allowing more blood to flow that will deliver more oxygen to the tissues and, hopefully, will improve exercise capacity and quality of life,” Scandurra told Cardiology Today’s Intervention. “As soon as the device is implanted and activated, we see the hemodynamic benefit.”
He said the company may have won the competition because the device “represents a completely new pathway, a new mechanism of action and a totally innovative approach to treating pulmonary hypertension.”
The prize money will augment ongoing research and development efforts, Scandurra said in an interview, noting that the company is planning a clinical trial of a longer-term implant of the device under the FDA’s Early Feasibility Studies program. Eventually, a pivotal study will be conducted that would be the basis for an application for FDA approval, he said. – by Erik Swain
Scandurra J. Shark Tank Innovation Competition. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Disclosure: Scandurra is an employee of Aria CV Inc.