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JEWISH LIGHT
HEART HEALTH
February 2, 2022
Israeli startup’s implant could ease congestive heart failure BY BRIAN BLUM ISRAEL21C.ORG
Congestive heart failure (CHF) is a leading cause of mortality – only 30% of patients survive 10 years, and less than half get even five years. Israeli startup Restore Medical has developed a new approach to treating CHF using an implantable device. CHF develops when the ventricles of the heart can’t pump enough blood volume. Eventually, blood and other fluids back up inside the lungs, abdomen, liver and lower body. Fluid in the lungs leads to shortness of breath and fatigue. CHF affects 6.2 million people in the United States and more than 64 million people globally. It affects nearly 10 out of every 1,000 people over the age of 65, in whom it is the most common diagnosis for hospitalized patients. Heart failure doesn’t mean the heart has stopped working; rather, because the blood returns to the heart faster than it can be pumped out, the heart becomes congested. The body tries to compensate by signaling the heart to beat faster, to take less time for refilling after it contracts. But over the long run, less blood circulates and the extra effort can cause heart palpitations. CHF most commonly damages the left ventricle – that’s the part of the heart that pumps blood to the body. The right ventricle’s job is to push blood into the lungs. The damaged left ventricle becomes dilated, like a balloon, to make room for the extra blood. The only treatment for CHF is pharmaceuticals such as ACE inhibitors, diuretics and vasodilators. Restore Medical developed an implant that is inserted into the pulmonary artery. It changes the pressure on the healthy right ventricle, enabling it to support the failed left ventricle, explains Gilad Marom, Restore Medical’s CEO. The implant is dubbed ContraBand. “Contra,” which means “in opposition to,” refers to this contrarian push of one ventricle onto the other. The ContraBand implant is delivered to the heart via catheter in much the same way that stents are introduced – through the femoral vein in the thigh. “The procedure is relatively simple and takes less than an hour,” Marom tells ISRAEL21c. “Patients can be discharged the next day.” ContraBand is not a cure for CHF. It would be an additional treatment option along with pharmaceuticals. “It won’t make the disease go away,” Marom says. “No one can do that. But it will reduce symptoms and it can reduce hospitalizations or trips to the doctor when fluid gets in the lungs.” That’s significant because CHF is responsible for 4% of all hospitalizations worldwide and is the leading cause of repeat hospitalizations, with 25% of patients returning a month after discharge. Restore Medical has conducted trials on animals with CHF and has treated three human patients – two in Belgium at ZNA Medical Center in Antwerp, and one in Israel at Kaplan Medical Center in Rehovot. The next step is to recruit another 15 patients and follow up for six months, in order to gather data to seek FDA (United States) and CE (European Union) regulatory approval. Marom hopes that a fully commercialized version of ContraBand will be available to help patients by 2026. He expects to start an initial conversation with the FDA this year.
He emphasizes that the functionality of the ContraBand device is completely reversible, “which is very rare in the cardio implant world.” If a patient no longer needs an implant or cannot tolerate it, “with any other cardiac device, the only ‘bailout’ is surgery,” Maron says. ContraBand, however, can be “deactivated” rather than removed, he claims. Restore Medical was founded by medical director Dr. Elchanan Bruckheimer; VP Clinical Affairs Stephen Bellomo; and Aaron Feldman, today a board member. Marom was recruited in 2019 from Edwards Life Sciences, where he worked for 12 years in Israel and the United States. There, he focused on transcatheter heart valves, taking three cardiovascular implants from inception to clinical success. “When I joined Edwards, the majority of
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Restore Medical executives, from left: VP R&D Tsur Genosar, CEO Gilad Marom, cofounder and VP Clinical Affairs Stephen Bellomo. PHOTO: EYAL TOUEG
the clinical community said it was impossible to replace the heart value other than by surgery. We proved the opposite,” he tells ISRAEL21c. While heart valves can be “fixed,” CHF had no solution. That’s why he accepted the offer to lead Restore Medical. “I recognized the opportunity to be in a ‘blue ocean’ situation, to prove there is another way to treat patients,” he says. “This was a brand-new approach, so the decision to join was relatively easy.”
The company is based in Or Yehuda and employs six people. The Crunchbase website says the company has raised $1 million; Marom hinted that it was substantially more than that. Marom notes that Covid-19 has been tough for CHF patients. “People were afraid to go to the hospital due to Covid. And hospitals might not be as accessible.” That creates an acute need for “a device like ContraBand which helps already sick patients from getting more complications.”
Caring for Your Heart During COVID-19 For people who have had COVID-19, lingering heart problems can affect their recovery. COVID-19 has a 20 percent greater chance of affecting the heart than all other viruses. It can cause a number of conditions, including heart attacks, heart failure, rapid heart rhythms, blood clots, and inflammation of the heart and the sac surrounding the heart. For patients who have been diagnosed with COVID-19 and are admitted to the hospital, cardiologists are involved in their treatment plans and closely monitor their condition for effects or complications they may experience due to the disease. Patients who have a milder form of the disease that does not require hospitalization are strongly encouraged to receive an evaluation from their primary care physician or a cardiologist, especially if they experience chest pains, heart palpitations, or shortness of breath. People with poor cardiovascular health are at increased risk of severe illness from COVID-19, so it’s more important than ever to know your risk factors for heart and vascular disease. This includes
traditional risk factors such as a family history of heart disease or hypertension, and less well-known risk factors like autoimmune disease, prediabetes, or significant hormonal changes due to pregnancy or menopause. There are many things you can do every day to prevent cardiovascular disease: increase physical activity, aim for a healthy weight, control blood sugar, practice stress management, monitor blood pressure and cholesterol, live smoke-free, and eat a well-balanced nutritious diet. These healthy living habits decrease the complications of COVID-19 as well. Expert advice and prevention are powerful allies. We are fortunate to have amazing cardiologists at St. Luke’s who are all passionate about patient care and who are eager to help. If you or a loved one has been diagnosed with a heart condition that needs a first diagnosis or a second opinion, trust the heart specialists at St. Luke’s Heart & Vascular Institute. Contact us at 314-205-6801 or visit stlukes-stl.com/ hearthealth.
Keith Mankowitz, MD, St. Luke’s Hospital
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