Latest news with #TAH
Yahoo
a day ago
- Business
- Yahoo
BiVACOR's Total Artificial Heart Receives FDA Breakthrough Device Designation
Clinical-stage company earns key regulatory milestone as it advances a first-of-its-kind heart replacement system toward wider use. HUNTINGTON BEACH, Calif., May 30, 2025--(BUSINESS WIRE)--BiVACOR, a clinical-stage medical device company developing the world's first titanium Total Artificial Heart (TAH), today announced that its device has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The designation supports the BiVACOR TAH as a bridge to transplant (BTT) for adults with severe biventricular or univentricular heart failure where current treatments, including LVADs, are not viable. The FDA's Breakthrough Device program is reserved for technologies that may significantly improve outcomes for patients with life-threatening or irreversibly debilitating conditions. It offers priority regulatory interaction and accelerated pathways to approval. "This is more than a regulatory milestone. It's a validation of a concept we've spent decades proving that a fully implantable, total artificial heart isn't just possible, it's necessary," said Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR. "Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The Breakthrough Device Designation puts us on a faster track to deliver exactly that." The milestone follows the first phase of BiVACOR's FDA Early Feasibility Study, where five patients in the U.S. received the TAH between July and November 2024. Based on positive safety and performance data, the FDA approved the expansion of the trial to include 15 additional patients starting later this year. BiVACOR's device represents a new category in artificial heart technology. Compact enough to fit most men and women, the TAH uses magnetic levitation, similar to maglev trains, to suspend a single dual-sided rotor. This rotor simultaneously powers the right and left circulatory systems, mimicking the natural heartbeat without valves or mechanical wear points. Its simplified design allows for pulsatile flow, large blood gaps to reduce trauma, and long-term durability. "We've seen every kind of artificial heart technology over the last four decades, but this is the first system I've encountered that combines engineering elegance, efficiency, and safety with true clinical viability," said William Cohn, MD, BiVACOR Chief Medical Officer and heart surgeon at the Texas Heart Institute. "The early results are remarkable with no strokes, no device-related complications, and a safety profile unlike anything in this space. With Breakthrough status in hand, we're entering the next phase with the wind at our backs and real momentum to bring this to more patients." Heart failure affects more than 6 million Americans, and thousands of patients each year progress to irreversible biventricular failure. However, the number of available donor hearts remains stagnant, with fewer than 4,500 transplants performed annually in the U.S. BiVACOR is targeting this critical gap with a durable artificial replacement engineered for eventual long-term support. The BiVACOR TAH is currently investigational and not approved for commercial use. About BiVACOR BiVACOR® is a clinical-stage medical device company developing a fully implantable, magnetically levitated Total Artificial Heart for long-term support of patients with end-stage biventricular heart failure. Founded by biomedical engineer Daniel Timms, PhD, and backed by leading experts in cardiovascular medicine including Dr. William E. Cohn and Dr. O.H. (Bud) Frazier, the company is conducting an FDA-approved Early Feasibility Study in the U.S. Headquartered in Huntington Beach, CA, with clinical operations in Houston and engineering offices in Gold Coast, Australia, BiVACOR is committed to addressing the global shortage of donor hearts through advanced, scalable technology. Learn more at View source version on Contacts Media Contact: Dana SummersPenman PRdana@
Business Wire
a day ago
- Business
- Business Wire
BiVACOR's Total Artificial Heart Receives FDA Breakthrough Device Designation
HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--BiVACOR, a clinical-stage medical device company developing the world's first titanium Total Artificial Heart (TAH), today announced that its device has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). 'This is more than a regulatory milestone. It's a validation of a concept we've spent decades proving that a fully implantable, total artificial heart isn't just possible, it's necessary,' said Daniel Timms, PhD, Founder and CTO of BiVACOR Share The designation supports the BiVACOR TAH as a bridge to transplant (BTT) for adults with severe biventricular or univentricular heart failure where current treatments, including LVADs, are not viable. The FDA's Breakthrough Device program is reserved for technologies that may significantly improve outcomes for patients with life-threatening or irreversibly debilitating conditions. It offers priority regulatory interaction and accelerated pathways to approval. 'This is more than a regulatory milestone. It's a validation of a concept we've spent decades proving that a fully implantable, total artificial heart isn't just possible, it's necessary,' said Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR. 'Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The Breakthrough Device Designation puts us on a faster track to deliver exactly that.' The milestone follows the first phase of BiVACOR's FDA Early Feasibility Study, where five patients in the U.S. received the TAH between July and November 2024. Based on positive safety and performance data, the FDA approved the expansion of the trial to include 15 additional patients starting later this year. BiVACOR's device represents a new category in artificial heart technology. Compact enough to fit most men and women, the TAH uses magnetic levitation, similar to maglev trains, to suspend a single dual-sided rotor. This rotor simultaneously powers the right and left circulatory systems, mimicking the natural heartbeat without valves or mechanical wear points. Its simplified design allows for pulsatile flow, large blood gaps to reduce trauma, and long-term durability. 'We've seen every kind of artificial heart technology over the last four decades, but this is the first system I've encountered that combines engineering elegance, efficiency, and safety with true clinical viability,' said William Cohn, MD, BiVACOR Chief Medical Officer and heart surgeon at the Texas Heart Institute. 'The early results are remarkable with no strokes, no device-related complications, and a safety profile unlike anything in this space. With Breakthrough status in hand, we're entering the next phase with the wind at our backs and real momentum to bring this to more patients.' Heart failure affects more than 6 million Americans, and thousands of patients each year progress to irreversible biventricular failure. However, the number of available donor hearts remains stagnant, with fewer than 4,500 transplants performed annually in the U.S. BiVACOR is targeting this critical gap with a durable artificial replacement engineered for eventual long-term support. The BiVACOR TAH is currently investigational and not approved for commercial use. About BiVACOR BiVACOR® is a clinical-stage medical device company developing a fully implantable, magnetically levitated Total Artificial Heart for long-term support of patients with end-stage biventricular heart failure. Founded by biomedical engineer Daniel Timms, PhD, and backed by leading experts in cardiovascular medicine including Dr. William E. Cohn and Dr. O.H. (Bud) Frazier, the company is conducting an FDA-approved Early Feasibility Study in the U.S. Headquartered in Huntington Beach, CA, with clinical operations in Houston and engineering offices in Gold Coast, Australia, BiVACOR is committed to addressing the global shortage of donor hearts through advanced, scalable technology. Learn more at
Yahoo
18-03-2025
- Health
- Yahoo
A Man Lived Over 100 Days With a Titanium Heart. What If He's the Future of Medicine?
"Hearst Magazines and Yahoo may earn commission or revenue on some items through these links." Millions of people around the world suffer from heart failure with not nearly enough donors to go around. A new life-saving titanium device called the BiVACOR Total Artificial Heart (TAH) recently kept a patient alive for more than 100 days while awaiting a donor heart. Although designed as a stop-gap device for would-be heart donor recipients, the titanium heart could be a future permanent heart replacement for those too old or sick to undergo a transplant. Being a man with a heart of stone isn't usually a compliment, but a heart of titanium, on the other hand, might just save your life. At least that's true for one particular Australian man who lived with an artificial titanium heart while waiting for a match for a heart transplant. According to St. Vincent's Hospital Sydney in Australia, the man eventually received that heart and is recovering well. The patient was the sixth person to ever receive the BiVACOR Total Artificial Heart (TAH), the first to do so in Australia, and also the first to live with the device for more than a month, but he didn't stop there—his titanium ticker was pumping blood for more than 100 days. That's particularly impressive as the mechanical device was initially designed as a stopgap measure as patients with heart failure wait for a donor heart—and those waiting lists can be to Nature, 7 million adults live with heart failure in the U.S. alone yet only 4,500 heart transplants were performed in 2023. That leaves many millions across the globe in need of short-term solutions while waiting for a heart, and it appears BiVACOR can help in the most severe circumstances. The five previous trials of the device, all in the United States, also were successes though they featured earlier versions of the device that weren't designed for at-home support. The first device was implanted on July 9, 2024, at The Texas Heart Institute. 'Utilizing advanced MAGLEV technology, our TAH brings us one step closer to providing a desperately needed option for people with end-stage heart failure who require support while waiting for a heart transplant,' Daniel Timms, the CTO of BiVACOR, said after the successful implantation in July. Suitable for most men and women, this small device uses a titanium biventricular rotary pump that, as Timms describes, contains a magnetically levitated rotor that pumps blood and therefore replaces the need for the failing heart's ventricles. This MAGLEV technology ensures that there's no wear-and tear of the device, a defect that could prove fatal for someone relying on the titanium heart, or incidences of blood trauma.[WHOEVER TOP EDITS, READ THAT LAST SENTENCE. DOESNT THAT NOT MAKE SENSE? FEEL WE CAN JUST CUT] The TAH is currently only a short-term solution for those with heart failure, but that may not always be the case. In some cases, patients who are too old or sick for a transplant could use the BiVACOR TAH as a permanent replacement. However, Nature notes that the device still needs to go through trials for such an application. 'Many end-stage heart disease patients are actually too sick to qualify for heart transplants,' heart surgeon Jacob N. Schroder, surgical director of Advanced Heart Failure at Duke, who performed the second BiVACOR TAH operation in November 2024, said in a press statement. 'Current technologies are effective for some patients but still leave others without options. Having another way to bridge a path to transplant would fill a tremendous void and truly be a lifesaver.' For now, BiVACOR TAH is only accessible in clinical trials approved by the FDA, and the Australian implantation is part of Monash University's Artificial Heart Frontiers Program that aims to commercialize life-saving heart failure devices. BiVACOR TAH isn't quite like the flexible membranes that made up replacement hearts in the past, but its six-for-six winning streak certainly has cardiologists and surgeons around the world taking notice. You Might Also Like The Do's and Don'ts of Using Painter's Tape The Best Portable BBQ Grills for Cooking Anywhere Can a Smart Watch Prolong Your Life?
Al Jazeera
17-03-2025
- Health
- Al Jazeera
Could titanium hearts be a solution to a global heart donor shortage?
An Australian man with heart failure has become the first person in the world to survive more than 100 days with an artificial titanium heart as he waited to receive a donor transplant. The breakthrough raises hopes that fully mechanical hearts could one day replace the need for donor transplants. Diseases of the heart and surrounding blood vessels are the leading cause of death globally, killing about 17.9 million people each year, according to the World Health Organization. Here's what to know about how the titanium heart works, and can it solve the global donor shortage? What happened with the man with an artificial heart? The man in his forties, who declined to be identified, became the first person to be discharged from hospital with a fully artificial heart implant. During a six-hour surgery in November 2024 at St Vincent's Hospital in Sydney, the BiVACOR Total Artificial Heart (TAH) made of titanium was implanted into the patient, who was experiencing severe heart failure. After spending a few weeks in intensive care, followed by observation in the hospital, the patient was discharged in early February. He lived with the artificial heart for 105 days before receiving a donor heart transplant on March 6, and is currently recovering well, according to his doctors. Has anyone else had a titanium heart transplant? In July 2024, a 57-year-old man with end-stage heart failure received the BiVACOR TAH at Baylor St Luke's Medical Center in Houston, Texas. This was the first human implantation of the titanium heart, serving as a bridge to a real heart transplant. The device supported the patient for eight days in the hospital until a donor heart became available. Between July and November 2024, four other men in their mid-forties to mid-sixties in the US also received the BiVACOR TAH. Each patient successfully transitioned to a donor heart transplant and was discharged from the hospital within a month. None of the US patients left the hospital with the device. Could it solve a heart donor shortage? The titanium heart could possibly help address the donor shortage by keeping patients alive while they wait for a real heart transplant. However, it is still uncertain whether it could ever serve as a permanent replacement for a human heart. The procedures in the US, for example, were part of a five-person early feasibility study approved by the country's Food and Drug Administration (FDA), with plans to expand the trial to 15 more patients in the coming months. The goal of such trials is to determine whether the titanium heart can safely keep patients alive while they wait for a transplant. Finding a donor heart isn't easy because there aren't enough available, and matching a heart to a patient can take time. In the United Kingdom, for example, patients on the regular waiting list for a donor heart usually wait 18 to 24 months. Those in urgent or emergency cases get priority and may receive a heart sooner because their condition is more critical. Heart failure affects at least 26 million people worldwide, including 6.2 million adults in the US. However, heart transplants remain rare, with fewer than 6,000 performed globally each year, reserved only for the most severe cases. How does a titanium heart work? The titanium artificial heart works very differently from a real heart. A natural heart beats by squeezing and relaxing to pump blood, but this artificial heart does not beat at all. Instead, it has a spinning disc inside that moves the blood around the body. This disc floats in place using magnets, so it never touches anything, meaning there's no friction and less chance of it wearing out over time. To keep running, the artificial heart needs a small external controller, which is powered by batteries during the day and plugged into a power source at night. A thin cable runs under the skin to connect the heart to this controller. Most artificial heart devices only replace one side of the heart, usually the left side. But the BiVACOR heart completely replaces the entire organ, making it an option for people whose whole heart is failing and who might not survive while waiting for a donor heart. Why was titanium chosen for an artificial heart? Titanium was chosen because it is strong, lightweight, and resistant to corrosion, making it ideal for long-term use in the body. Unlike other artificial hearts, which have multiple moving parts that can wear out, this one has only one spinning disc, reducing the risk of failure. Before the development of the BiVACOR artificial heart, the SynCardia Total Artificial Heart was the most commonly used device for patients with severe heart failure. Approved by the FDA in the early 2000s, the SynCardia heart is constructed primarily from polyurethane, a type of durable plastic. Over the past two decades, it has been temporarily implanted in more than 2,000 patients across 20 countries while they awaited donor heart transplants. However, the SynCardia device is relatively large and complex, with multiple moving parts that can wear out over time. Scientists have also explored using animal organs to treat heart failure. In January 2022, surgeons at the University of Maryland Medical Center in the US performed the first transplant of a genetically modified pig heart into a human patient with severe heart disease. Despite initial success, the patient developed complications and passed away approximately two months later. How long could a titanium heart last? Currently, no one knows the exact lifespan of the titanium heart in humans. In lab tests, the device has operated continuously for more than four years without signs of failure. While the Australian man's 100-day trial was the longest recorded use of the titanium heart in a human, the BiVACOR team has said further trials are needed to determine whether it could become a long-term replacement rather than just a temporary bridge to a transplant. The development of the device began in 2001 when Daniel Timms, inspired by his father's heart condition, started working on the concept during his PhD at Queensland University of Technology in Australia. Since then, it has undergone years of research, redesign, and testing in animals like calves and pigs. What challenges come with an artificial heart? One of the biggest challenges with organ transplants is immune rejection, where the body attacks the new organ as a foreign object. Since the BiVACOR titanium heart does not contain any biological tissue, the risk of rejection is lower compared with donor hearts or pig heart transplants. However, trial protocols indicate patients still take blood-thinning medication to prevent clotting around the device. Additionally, patients with the BiVACOR heart must stay connected to an external power source at all times. While portable battery packs allow for some mobility, the process still requires lifestyle adjustments such as battery recharging, avoiding activities that could damage the external parts, and planning travel carefully to ensure access to power.
Daily Tribune
14-03-2025
- Health
- Daily Tribune
Man Survives 100 Days with Artificial Titanium Heart in Groundbreaking Medical Trial
A groundbreaking medical trial in Australia has seen a man survive for 100 days with an artificial titanium heart, marking a significant milestone in cardiac technology. The patient, a man in his 40s who has chosen to remain anonymous, received the BiVACOR Total Artificial Heart (TAH) in November at St. Vincent's Hospital Sydney. In February, he became the first person to be discharged from the hospital while relying on the device. Earlier this month, he successfully underwent a donor heart transplant and is now recovering well, according to a joint statement from St Vincent's Hospital, Monash University, and BiVACOR, the company behind the artificial heart. The BiVACOR TAH is designed to replace both ventricles of a failing heart. It features a single moving part—a magnetically levitated rotor—constructed from titanium, eliminating the need for mechanical bearings or valves that could wear out over time. Australian bioengineer Daniel Timms, who founded BiVACOR after losing his father to heart disease, called the achievement a major step forward in heart failure treatment. "This milestone represents decades of hard work, and we are deeply grateful to the patient and his family for trusting our technology," Timms said. Professor Chris Hayward of the Victor Chang Cardiac Research Institute, who has been overseeing the patient's recovery, said the success of the device could transform the future of heart transplants. "Within the next decade, artificial hearts may become a viable alternative for patients who are unable to receive donor hearts in time," Hayward stated. The BiVACOR device has been undergoing trials in the United States as part of the FDA's Early Feasibility Study. Five patients have been implanted with the device so far, including a 58-year-old man in Texas last year, who survived for eight days before receiving a donor heart. Researchers hope the study will expand to 15 patients. The Australian trial is part of Monash University's Artificial Heart Frontiers Program, a AU$50 million ($31 million) initiative aimed at advancing artificial heart technology. Cardiovascular disease remains the leading cause of death worldwide, with around 18 million fatalities annually, according to the World Health Organization. Experts believe that artificial hearts like the BiVACOR TAH could help address the shortage of donor hearts and improve survival rates for patients with end-stage heart failure. Medical researchers say further trials will be needed before the BiVACOR heart can be considered for widespread use, but this latest development marks a promising step forward in the field of cardiac care.
