Pulmonary arterial hypertension associated with congenital heart disease

Heartpoint Global is developing a device to adjust pulmonary blood flow in infants born with congenital heart disease, avoiding risky pulmonary artery banding. The Coral Gables, Florida–based startup recently won the Transcatheter Cardiovascular Therapeutics (TCT) conference’s Shark Tank Innovation Competition and is now preparing to submit its technology to the FDA for breakthrough device designation. Heartpoint Global designed its multi-lumen IntelliStent system to restrict the blood flow in the arteries between the heart and lungs. The system can also allow a physician to later adjust the patient’s blood flow as they grow or their condition changes. The system includes self-expanding nitinol stents that can be placed and adjusted in the main pulmonary artery or its branches with minimally invasive catheter procedures instead of a sternotomy. The technology could prevent or act as a bridge to heart transplants, artificial hearts and other heart surgeries. “HeartPoint Global’s pioneering approach to treating pulmonary arterial hypertension caused by congenital heart disease and pulmonary arterial hypertension (PAH-CHD) stood out due to its potential to address a significant unmet clinical need,” Cardiovascular Research Foundation CEO and President Dr. Juan Granada said in an announcement of the company’s win at TCT. “We’re focused first on pulmonary arterial hypertension caused by congenital heart disease,” Heartpoint Global CEO and Chair Seth Bogner said in an interview with Medical Design & Outsourcing. “… This multi-lumen method of adjustability is already patented, and it’s applicable in every blood-carrying vessel in the body.” How Heartpoint designed IntelliStent Heartpoint designed its IntelliStent system to enter the body through the femoral vein and head up to the heart’s inferior vena cava, passing through the right atrium and right ventricle to reach the main pulmonary artery. The catheter system deploys the self-expanding stent in the main pulmonary artery and/or the right or left pulmonary arteries to restrict blood flow. To further restrict blood flow, another stent can be placed the same way inside the first stent. If more blood flow is needed later, the stents can be removed with a procedure similar to the minimally invasive catheter placement. Bogner said Heartpoint is patenting a proprietary balloon stent that could also be used to increase flow as necessary. The nitinol stents are partially coated with a nonpermeable polyurethane polymer and have radiopaque markers for placement visualization. The nitinol implants expand as they exit the catheter delivery system thanks to the nickel-titanium alloy’s superelastic properties, and they maintain their shape at body temperature due to nitinol’s shape memory properties, Bogner said. In animal studies so far, the implants reduced pulmonary pressure and endothelialized quickly but have not caused thrombosis or damaged the pulmonary artery or heart valves, Bogner said. What’s next for Heartpoint and its IntelliStent system After it wins regulatory approval for an initial indication of PAH-CHD, the company wants to use the system to treat left ventricular dilated cardiomyopathy (LV-DCM). In those cases, a patient’s left ventricle enlarges, shifting the interventricular septum to the right side of the heart. As the left ventricle expands, the muscle thins and weakens, reducing the heart’s ability to pump oxygenated blood. This condition can lead to heart failure or death if untreated. Bogner said he also sees potential for additional cardiac indications such as other kinds of pulmonary hypertension, congenitally corrected transposition of the great arteries (CCTGA), or to take the guesswork out of occluder sizing. The technology might also one day be used to help treat liver tissue interstitial fluid (TIF) in cirrhosis patients. “There are a lot of licensing opportunities and engineering opportunities because there are existing devices that could use our technology,” he said. “… A lot of engineers are going to be happy for a very long time.” But for now, Heartpoint is working on regulatory approval for PAH-CHD, planning for first-in-human clinical trials in the U.S. and overseas to start as soon as this year, with regulatory submission expected in 2025 and marketing authorization the year after. “We’re an American company that has European and Israeli subsidiaries, and we’re very focused on getting this into Europe as quickly as possible,” Bogner said.

Award Recognizes Breakthrough Innovation for INTELLISTENT®, Paving the Way for Citizens Worldwide to Receive Affordable, Cutting-Edge Cardiac Care NEW YORK , Oct. 25, 2023 /PRNewswire/ -- HeartPoint Global is pleased to announce that INTELLISTENT® the company's novel multi-lumen stent system for interventional adjustment of pulmonary blood flow in congenital heart disease, was the winner in the Shark Tank Innovation Competition at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. "HeartPoint Global's pioneering approach to treating Pulmonary Arterial Hypertension caused by congenital heart disease and pulmonary arterial hypertension (PAH-CHD) stood out due to its potential to address a significant unmet clinical need," said Dr. Juan F. Granada, MD, CEO and President of the Cardiovascular Research Foundation (CRF). "It was selected as the winner by a distinguished panel of judges, including physician innovators, physician investors, and experts actively involved in building companies and developing innovative, high-impact therapies." HeartPoint Global's INTELLISTENT® is a groundbreaking multi-lumen stent system for interventional adjustment of pulmonary blood flow to treat PAH-CHD. It reproduces the effects of the validated surgical therapy, pulmonary artery banding, and is patented in over 20 countries, including the U.S., European Union, and China. The device is placed in the main pulmonary artery and the arterial branches and allows for the adjustment of blood flow in the heart lung system. Patients with severe PAH can become surgical candidates after INTELLISTENT® treatment (bridge-to-surgery). The technology embedded in INTELLISTENT® will be used to treat many other indications. Previous successful pre-clinical tests of the implant system studied the direct placement of the device in the main pulmonary artery and bilateral delivery in the left and right pulmonary arteries and branches. Research presented at TCT by Dr. Elena K. Amin, MBChB, Pediatric Cardiologist at the University of California, San Francisco, and a member of HeartPoint Global's advisory board, demonstrated first proof-of-concept results showing that reversible pulmonary artery banding in left ventricle failure with preserved right ventricle function provides a novel alternative as a 'bridge-to transplant' or as an alternative to destination therapy in infants and children with advanced left ventricle dilated cardiomyopathy. Seth Bogner, Chairman and CEO of HeartPoint Global said, "We are deeply honored to be bestowed with this prestigious award. TCT stands as a pinnacle platform for highlighting innovation in cardiovascular medicine. Having our technology acknowledged by such a distinguished panel of judges is truly humbling. We are eager to forge ahead with HeartPoint Global's in-human trials and anticipate its substantial clinical impact in the future." The TCT Shark Tank Innovation Competition has partnered with the Jon DeHaan Foundation for six years to provide a $200,000 award for the winner. The Shark Tank Innovation Competition aims to identify and showcase the most groundbreaking concepts in modern cardiovascular medicine. This year, six companies were chosen to present at TCT. The Jon DeHaan Foundation is dedicated to supporting those working to advance cardiac medicine and provides grants and awards to individuals and companies who focus on innovative developments in cardiovascular medicine, including research, prevention, diagnosis, treatment, or rehabilitation. About HeartPoint Global As a pioneer of breakthrough medical solutions, HeartPoint Global (HPG) is paving the way for citizens worldwide to receive affordable, cutting-edge cardiac care. In response to the 92 percent of the world's population that has no access to cardiac surgery, the leading medical device company is on a mission to provide innovative, minimally invasive, and accessible cardiac care on a global scale to ensure those who would otherwise suffer from or die of cardiovascular disease receive the care they need. For more information, visit . About CRF and TCT The Cardiovascular Research Foundation (CRF) is one of the world's leading nonprofit organizations specializing in interventional cardiology innovation, research, and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 30 years, CRF has helped accelerate medical breakthroughs and educated doctors on the latest treatments for heart disease. CRF's centers of excellence include the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the premier educational meeting specializing in interventional cardiovascular medicine. Every year TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit and . Media Contact Brigit Hennaman VP, Rubenstein Public Relations [email protected] 212-805-3005 SOURCE HeartPoint Global