Microvascular Angina

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.

Innovation for patients suffering from angina due to persistent ischemic heart disease Santa Clara, CA - February 26, 2024 – VahatiCor, Inc., a company dedicated to improving the quality of life of patients with persistent ischemic heart disease, today announced the treatment of the first patient with the A-FLUX Reducer System, a treatment for patients with angina or chest pain. Angina is often caused by reduced blood flow to the heart. This condition can occur in people with or without significant blockages in their large coronary arteries. It is frequently accompanied by decreased blood flow in the very small blood vessels branching off the coronary arteries, a condition known as coronary microvascular dysfunction or microvascular angina. The A-FLUX Reducer implant is placed in the coronary sinus, the largest vein in the heart, and is designed to provide more blood flow to the ischemic portion of the heart and improve patient symptoms and quality of life. The first patient received the A-FLUX Reducer implant through the Special Access Program (SAP) of Health Canada. A prospective multi-center clinical study of the device is scheduled to begin enrollment this year. “We have many interventional or surgical revascularization options for patients with advanced large coronary artery disease. However, a significant proportion still suffer from angina. The A-FLUX Reducer could help to fill that therapeutic void. It was an honor to perform the first-in-human implant and the patient is doing great,” said Dr. Jean-Michel Paradis, specialist in coronary and structural interventional cardiology at Quebec Heart and Lung Institute, who co-treated the first patient. “The A-FLUX Reducer System is a promising intervention with the potential to provide a predictable and low-risk treatment for a growing population of patients with angina symptoms that do not respond well to medicines and lifestyle changes,” added Dr. Can Manh Nguyen, interventional cardiologist who co-treated the first patient with Dr. Paradis. More than 20 million people in North America and Europe have ongoing angina symptoms and 4 million undergo invasive diagnostic angiograms per year.1-4 “At VahatiCor, we’re driven to improve patient outcomes with solutions that provide rapid relief and long-term effectiveness. While many interventions are available to treat the blockages in the large coronary arteries, very few options exist for an even larger group of patients with microvascular angina,” said Howard Edelman, CEO of VahatiCor. “We are encouraged by the positive early clinical experience with A-FLUX and are moving forward quickly to a larger study that will support the availability of the device for more patients.” About VahatiCor, Inc. VahatiCor, Inc., a member of the T45 Labs portfolio, is developing medical devices that address unmet clinical needs to elevate the standard of care for people with angina and other heart conditions. The team at VahatiCor recognizes the profound impact these conditions can have on a patient’s health, happiness, and overall quality of life and is dedicated to finding solutions. ### The A-FLUX Reducer System is an investigational medical device that is not available for commercial distribution. Media Contact Mark Niggli, CCO media@vahaticor.com 1. Mozaffarian D, et al. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016; 133:e38–e360 2. European Society of Cardiology, Disease of the smallest heart blood vessels is important global health problem. 27 May 2021. 3. Cook S, Walker A, Hügli O, Togni M, Meier B. Percutaneous coronary interventions in Europe: prevalence, numerical estimates, and projections based on data up to 2004. Clin Res Cardiol. 2007;96(6):375 382. 4. Patel MR, Peterson ED, Dai D, et al. Low diagnostic yield of elective coronary angiography. N Engl J Med. 2010;362(10):886 895.

The AGENT DCB is an investigational device. Restricted by Federal law to investigational use only. Not available for sale in the U.S. AGENT Drug-Coated Balloon. (Credit: PRNewswire/Boston Scientific Corporation) Boston Scientific Corporation (NYSE: BSX) today announced positive 12-month results from the pivotal AGENT IDE clinical trial of the AGENT™ Drug-Coated Balloon (DCB).1 Primary endpoint findings from this first clinical trial in the U.S. to evaluate the safety and effectiveness of using a DCB to treat coronary in-stent restenosis (ISR) were presented in a late-breaking clinical trial session at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. While coronary stenting is commonly used to restore blood flow to the heart in patients with coronary artery disease, ISR – a condition in which the stented section of the artery becomes obstructed or narrowed by plaque or scar tissue – still occurs in some cases and is addressed in 10% of U.S. percutaneous coronary interventions.2,3 The AGENT DCB is a paclitaxel-coated balloon catheter designed to re-open these vessels and then transfer the therapeutic drug to the vessel wall to help prevent ISR reoccurrence. This trial met the primary endpoint of target lesion failure4 (TLF) at 12 months with the AGENT DCB demonstrating statistical superiority to uncoated balloon angioplasty (17.9% vs. 28.7%; P=0.006). These differences were mainly driven by significantly reduced rates of myocardial infarction related to the target vessel (TV-MI, or heart attack) and the need for a target lesion revascularization (TLR, or a repeated percutaneous coronary intervention) procedure. Overall, data demonstrated an approximate 38% relative risk reduction in TLF, and additional 12-month event rates for the AGENT DCB vs. uncoated balloon included: Zero definite/probable cases of clotting within the stent, known as stent thrombosis (0.0% vs. 3.9%, P=0.001) 51% risk reduction in TLR (12.4% vs. 24.0%, P=0.002) 49% risk reduction in TV-MI (6.4% vs. 12.3%, P=0.03) “Positive outcomes in this complex trial population – from the markedly lower rate of target lesion failure to the significant reduction in heart attack and no stent thromboses – support the AGENT DCB as an alternative treatment option for coronary in-stent restenosis,” said principal investigator Dr. Robert W. Yeh, section chief of interventional cardiology at the Beth Israel Deaconess Medical Center, and the Katz-Silver Family Professor of Medicine at Harvard Medical School. “Meaningful therapy advancements for this condition are critical, and the ability to reduce the risk of restenosis without using radiation or introducing another layer of metal stenting is a promising step forward.” The data presented today from this multicenter, prospective and randomized controlled AGENT IDE trial include the first 480 of 600 patients enrolled across 40 U.S. sites.5 Within the patient population, 44% had multiple stent layers in the target lesion, and 51% were diabetic. “These encouraging results add to the growing body of clinical evidence supporting the AGENT DCB, spanning nearly 7,400 patients in 14 completed and ongoing studies worldwide,” said Dr. Janarthanan Sathananthan, M.D., chief medical officer, Interventional Cardiology Therapies, Boston Scientific. “In light of the successful real-world use of the device outside the U.S., we look forward to using these encouraging data to support FDA approval and bringing this important therapy to more physicians and patients in need.” The AGENT DCB was approved in Japan in 2023 and received CE Mark in 2014 for the treatment of patients with ISR and previously untreated small vessel coronary disease. Used to treat more than 100,000 patients globally to date, this technology was granted Breakthrough Device designation by the U.S. Food and Drug Administration in 2021, a status intended to provide patients more timely access to novel devices that may provide a substantial improvement over existing therapies. Source: Company Press Release