Microvascular Angina

Demonstrated a Reduction of Symptoms with Short Procedural and Recovery TimesLeading Coronary Physiology Experts Appointed Co-Principal Investigators for Planned U.S. Early Feasibility Study SANTA CLARA, Calif., Oct. 28, 2024 /PRNewswire/ -- VahatiCor, a leader in cardiovascular innovation, is proud to announce the successful completion of its compassionate use study treating patients with the A-FLUX Reducer System™ for either obstructive coronary artery disease with persistent symptoms or symptomatic coronary microvascular dysfunction (CMD). The study, in which ten patients were implanted with A-FLUX (four with CMD and six with obstructive epicardial disease), marks a significant milestone in demonstrating the safety and early efficacy of a promising therapeutic option for patients suffering from these challenging and debilitating conditions. Continue Reading Based on the positive results from the compassionate use study, the Company plans to commence SERRA-I, its U.S. early feasibility study (EFS) exclusively focused on CMD patients. Coronary physiology experts Samit Shah, MD, PhD, FACC, FSCAI, an interventional cardiologist from the Yale School of Medicine, and Tim Van de Hoef, MD, PhD, FESC, an interventional cardiologist from University Medical Center Utrecht, the Netherlands will lead the trial as co-principal investigators. The A-FLUX Reducer System offers a novel, minimally invasive approach to directly improve flow within the coronary microvasculature and relieve anginal symptoms in patients with CMD. The A-FLUX Reducer System has innovative properties, including its atraumatic expansion and repositionable design. Post this "Our compassionate use study demonstrated the safety of the implant and a sustained therapeutic potential for the A-FLUX Reducer System with significant reductions in anginal symptoms," said Marwan Berrada-Sounni, Founder and Chairman, VahatiCor. "We are excited to address the unmet clinical needs of CMD patients and delighted to take the next step in initiating the SERRA-I EFS, upon FDA IDE approval, with Dr. Shah and Dr. Van de Hoef so that we can bring this important therapy to patients." Patients treated with the A-FLUX Reducer System reported rapid symptom improvements and returned to their daily activities with minimal recovery time. The short nine-minute average implantation procedure time and clinical outcomes highlighted the implant's potential to become a frontline device therapy for patients with persistently symptomatic CMD. "Patients with CMD, which is more common in women, experience significant symptoms that can happen at rest and during exertion," noted Dr. Shah. "There is a real need for an effective treatment for these patients. The A-FLUX Reducer System has innovative properties, including its atraumatic expansion and repositionable design. I look forward to supporting the development of clinical evidence for this novel therapy." The A-FLUX Reducer System is engineered with SwiftCell Technology™, a small-cell proprietary design based on computational modeling, to redistribute oxygen supply to the sub-endocardium layer of the heart muscle. As Dr. Van de Hoef explained, "About half of the patients undergoing an invasive angiography are found not to have obstructive coronary artery disease but, in fact, have coronary microvascular disease. Increasingly, more patients are likely to be identified as centers begin adopting the strong guidelines recently published by the European Society of Cardiology. These patients have no dedicated treatment available. Coronary sinus reduction and the advanced features of the A-FLUX device carry significant potential to help these patients return to normal daily activities." CMD occurs when the small coronary arteries within the heart muscle (coronary microvasculature) fail to dilate properly upon exertion, reducing blood flow to the heart muscle and creating discomforting angina symptoms. Millions of CMD patients worldwide suffer from persistent chest pressure, tightness, and chest pain, with no current viable options for symptom relief. Left untreated, diagnosis of CMD results in a fourfold elevated mortality risk compared to the general population.[1] About VahatiCor VahatiCor, Inc., a T45 Labs portfolio company, is committed to revolutionizing the treatment of coronary microvascular dysfunction through cutting-edge technologies and minimally invasive therapies to provide rapid relief and empower patients to reclaim their daily lives. To learn more, please visit : Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale. [1] Gdowski MA, Murthy VL, Doering M, Monroy-Gonzalez AG, Slart R, Brown DL. Association of Isolated Coronary Microvascular Dysfunction With Mortality and Major Adverse Cardiac Events: A Systematic Review and Meta-Analysis of Aggregate Data. J Am Heart Assoc. 2020 May 5;9(9):e014954. doi: 10.1161/JAHA.119.014954. Epub 2020 Apr 29. PMID: 32345133; PMCID: PMC7428565. SOURCE VahatiCor, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

New research has linked multiple types of per- and polyfluoroalkyl substances (PFAS, also known as 'forever chemicals') with increased risk of cardiovascular diseases in postmenopausal women. Specifically, the study reveals how PFAS chemicals interact with pro-inflammatory pathways in older women, providing potential explanations for the increased risk. New research from the University of Illinois Urbana-Champaign has linked multiple types of per- and polyfluoroalkyl substances (PFAS, also known as "forever chemicals") with increased risk of cardiovascular diseases in postmenopausal women. Specifically, the study reveals how PFAS chemicals interact with pro-inflammatory pathways in older women, providing potential explanations for the increased risk. "Previous research suggests PFAS exposures may play a role in the development of cardiovascular disease during the menopause transition, but the biological mechanisms were not well understood," said lead study author Alicia Arredondo Eve, a postdoctoral researcher in the Department of Food Science and Human Nutrition (FSHN) in the College of Agricultural, Consumer and Environmental Sciences (ACES) at Illinois. "We focused on specific PFAS chemicals as well as the cardiovascular diseases that are more common in older women." It's difficult to escape PFAS. The man-made chemicals coat nonstick pans, waterproof clothing, food wrappers, receipts, and many more items we come in contact with daily, not to mention being present in much of our water supply. Some forms -- and there are thousands of chemical variants -- could persist in the environment for hundreds or thousands of years, hence their "forever chemicals" moniker. Not surprisingly, studies suggest nearly all Americans carry PFAS in their blood and other bodily tissues. But premenopausal women are a little better off. Thanks to childbirth, breastfeeding, and their monthly menstrual cycle, premenopausal women expel more PFAS than men and postmenopausal women. After menstruation stops, PFAS accumulates and can cause problems. Scientists are still piecing together exactly what PFAS chemicals do in the body, but they appear to disrupt hormone signaling, interfering with normal reproductive and cardiovascular function. Most PFAS studies have focused on men or women during their reproductive years, but Arredondo Eve and co-author Zeynep Madak-Erdogan say postmenopausal women experience unique cardiovascular issues. Motivated to fill the knowledge gap, the researchers analyzed data and samples from 70 postmenopausal women in Turkey. About a third of the women had been diagnosed with coronary artery disease, the world's leading form of heart disease. Another third had coronary microvascular disease, which is common in postmenopausal women. The remaining third had no sign of heart disease. All of the samples were tested for the presence and levels of two long-chain "legacy" PFAS (no longer manufactured in the U.S.) -- PFOS and PFOA -- and a newer short-chain PFAS chemical known as PFBS. Next, the researchers used complex machine-learning techniques to analyze the relationships between the PFAS and various blood metabolites and proteins. "When you have multiple factors and you want to focus on one or two, machine learning techniques are very efficient in reducing that number," said Madak-Erdogan, an associate professor in FSHN. "We found PFOS was closely associated with coronary artery disease, while PFOA was more predictive of coronary microvascular disease." Further, the two chemicals interacted with proteins and pathways associated with inflammation. Chronic inflammation, triggered by stress, poor diet, infections, or other causes, is a risk factor for both coronary artery and coronary microvascular disease. While interactions with inflammatory pathways weren't a surprise given the diseases in question, an unexpected pattern emerged. "The PFAS we studied affected the abundance of circulating pro-inflammatory factors differently. We did not expect that," Arredondo Eve said. "PFOA and PFOS aren't that different in terms of their chemical structure. Our results show you can't lump all PFAS together." Higher levels of PFOA, which predicted coronary microvascular disease, were associated with higher levels of amino acids isoleucine and leucine and higher levels of pro-inflammatory cytokines. On the flipside, higher PFOS, related to coronary artery disease, was associated with lower isoleucine and leucine levels. In addition to these opposing effects on metabolites, each PFAS was associated with a distinct set of pro-inflammatory proteins. The researchers say further preclinical research is needed to understand the mechanistic basis of these differences. Ultimately, the study corroborates earlier research linking exposure to PFAS with cardiovascular disease in postmenopausal women, providing hints at how the chemicals interact with pro-inflammatory processes in the body. Unfortunately, the authors say there's not much women can do to get rid of PFAS after they get into the body. Instead, they caution women to avoid prolonged exposure by choosing PFAS-free clothing, cookware, and other materials. "We need more education as to how we can reduce our exposure to PFAS," Madak-Erdogan said. "There also needs to be more action to regulate and mitigate these chemicals getting into the environment." The team plans to continue studying the effects of PFAS on women's health.

The Agent DCB is a balloon catheter coated with paclitaxel that delivers a therapeutic dose of medication to the vessel wall, helping to avoid ISR recurrence Boston Scientific's corporate headquarters in Massachusetts, US. (Credit: Boston Scientific Corporation) Boston Scientific has received the US Food and Drug Administration (FDA) approval for the Agent Drug-Coated Balloon (DCB) to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease. The Agent DCB is a balloon catheter coated with paclitaxel that delivers a therapeutic dose of medication to the vessel wall, helping to avoid ISR recurrence. It can be used as an alternative to conventional procedures such as balloon angioplasty, additional layers of stenting, or radiation. The Agent DCB is now said to be the first coronary drug-coated balloon in the US to offer safe, effective options in ISR treatment. The approval follows the FDA’s Breakthrough Device Designation for the technology in 2021. Boston Scientific interventional cardiology therapies president Lance Bates said: “With more than 100,000 patients treated globally to date in both clinical and commercial settings, we are very pleased to introduce this proven therapy as the first drug-coated coronary balloon in the US. “The Agent DCB addresses a critical unmet need by providing a dedicated treatment option for the challenging condition of ISR and we look forward to offering US physicians the opportunity to treat their patients with this novel device.” The approval was based on the positive results from the multicentre, prospective, randomised controlled Agent IDE study. It recruited 600 patients at 40 US sites. The trial met its primary endpoint of target lesion failure (TLF) at 12 months in the prespecified interim analysis of the first 480 enrolled patients. Agent DCB showed statistical superiority to uncoated balloon angioplasty. Other findings were low adverse event rates at 12 months, a 49% reduction in the risk of a heart attack at the target vessel, and zero definite/probable cases of clotting within the stent. Patients with ISR and untreated small artery coronary disease can receive Agent DCB in Europe, certain regions of Asia Pacific, and Latin America. Boston Scientific intends to introduce the technology to the American market in the upcoming months. Last month, the medical device company secured the FDA’s expanded approval for the WaveWriter spinal cord stimulation (SCS) systems.