Latest news with #TotalArtificialHeart
Associated Press
7 days ago
- Health
- Associated Press
BiVACOR's Total Artificial Heart Receives FDA Breakthrough Device Designation
HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--May 30, 2025-- 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 CONTACT: Media Contact: Dana Summers Penman PR [email protected] KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: CARDIOLOGY BIOTECHNOLOGY FDA HEALTH GENERAL HEALTH HEALTH TECHNOLOGY OTHER SCIENCE MEDICAL DEVICES RESEARCH SCIENCE CLINICAL TRIALS SOURCE: BiVACOR Copyright Business Wire 2025. PUB: 05/30/2025 11:40 AM/DISC: 05/30/2025 11:38 AM
Yahoo
13-03-2025
- Health
- Yahoo
Australian Man Survives a Record 105 Days with Artificial Titanium Heart While Awaiting Donor
An Australian man with severe heart failure lived for a record 105 days with a metal heart while he waited for a donor heart to become available. He's the first person in the world to be discharged from the hospital with the titanium device, living at home for about a month before receiving his donor heart. The transplant took place on November 22, 2024, during a six-hour procedure at St. Vincent Hospital Sydney, according to a statement from Monash University. The transplant was part of the hospital's Artificial Heart Frontiers Program, which designs and tests new devices like pumps as well as the BiVACOR's Total Artificial Heart (TAH) — which this patient received. Related: P.E. Teacher, 23, 'Felt Something Was Wrong' After First Marathon, Learns He Has Heart Disease a Week Later (Exclusive) The man, who declined to be identified, is in his early 40s and from New South Wales, Australia. He was well enough to be discharged from the hospital in early February with his artificial titanium heart and received his donor heart on March 6. Now he is "recovering well," according to the Monash University statement. The successful procedure 'ushers in a whole new ball game for heart transplants,' Professor Chris Hayward, a cardiologist at St. Vincent Hospital, said. 'Within the next decade, we will see the artificial heart becoming the alternative for patients who are unable to wait for a donor heart or when a donor heart is simply not available.' Never miss a story — sign up for to stay up-to-date on the best of what PEOPLE has to offer, from celebrity news to compelling human interest stories. The titanium device has a small external controller with rechargeable batteries, according to manufacturer BiVACOR, which says it's 'designed to be a long-term device that can replace the total function of the patient's native heart.' The first implantation of the metal heart took place at the Texas Heart Institute at Baylor St. Luke's Medical Center in Texas Medical Center last July. Four more implants have taken place in the U.S., but this case marks the longest someone has lived with the heart while awaiting a donor. 'The long-term ambition is for implant recipients to be able to live with their device,' the statement says, 'without needing a heart transplant.' Read the original article on People
CNN
12-03-2025
- Health
- CNN
Man lives for 100 days with artificial titanium heart in successful new trial
An Australian man lived for 100 days with an artificial titanium heart while he awaited a donor transplant, the longest period to date of someone with the technology. The patient, a man in his 40s who declined to be identified, received the implant during surgery at St. Vincent's Hospital Sydney last November. In February, he became the first person worldwide to leave hospital with the device, which kept him alive until a heart donor became available earlier this month. According to a statement issued Wednesday by St Vincent's Hospital, Monash University and BiVACOR, the US-Australian company behind the device, the man, who had severe heart failure, was 'recovering well.' The ability of the device to sustain him for so long is being celebrated as a sign the artificial heart could potentially offer a long-term option for people suffering heart failure. The device is still being trialed and has not yet been approved for general use. BiVACOR's founder, Australian bioengineer Daniel Timms, who invented the device following his father's death from heart disease, said it was 'exhilarating to see decades of work come to fruition.' 'The entire BiVACOR team is deeply grateful to the patient and his family for placing their trust in our Total Artificial Heart,' he said in the statement. 'Their bravery will pave the way for countless more patients to receive this lifesaving technology.' The BiVACOR Total Artificial Heart (TAH) has a single moving part, a levitated rotor that's held in place by magnets. As the name suggests, it's constructed from titanium and there are no valves or mechanical bearings that may be susceptible to wear. It pumps blood to the body and the lungs, replacing both ventricles of a failing heart. Cardiovascular diseases are the leading cause of death globally killing around 18 million people each year, according to the World Health Organization. The long-term ambition is to use the device to save more people who languish on waiting lists for suitable donors. According to the US Health Department, about 3,500 people received heart transplants in 2024. Around 4,400 joined the waiting list the same year. Professor Chris Hayward, from the Victor Chang Cardiac Research Institute, said the BiVACOR heart ushered in 'a whole new ball game for heart transplants.' 'Within the next decade we will see the artificial heart becoming the alternative for patients who are unable to wait for a donor heart or when a donor heart is simply not available,' said Hayward, who is overseeing the Australian patient's recovery and was involved in preparing the device for clinical trials. The device has already been tested in the Food and Drug Administration's Early Feasibility Study in the United States, which saw five patients successfully implanted with the device. The first was last July, when a 58-year-old man suffering end-stage heart failure received the implant during surgery at Texas Medical Center. It kept him alive for eight days until a donor was available. Four other patients followed in the study, which examined the safety and performance of the device, while they waited for a donor transplant. It's hoped the trial will expand to 15 patients. The Australian implant was the first in a series planned by Monash University's Artificial Heart Frontiers Program, a 50 million Australian dollar ($31 million) program to develop and commercialize three devices to treat heart failure.
Saudi Gazette
12-03-2025
- Health
- Saudi Gazette
Man lives for 100 days with titanium heart in successful new trial
BRISBANE — An Australian man lived for 100 days with an artificial titanium heart while he awaited a donor transplant, the longest period to date of someone with the technology. The patient, a man in his 40s who declined to be identified, received the implant during surgery at St. Vincent's Hospital Sydney last November. In February, he became the first person worldwide to leave hospital with the device, which kept him alive until a heart donor became available earlier this month. According to a statement issued Wednesday by St Vincent's Hospital, Monash University and BiVACOR, the US-Australian company behind the device, the man, who had severe heart failure, was 'recovering well.' The ability of the device to sustain him for so long is being celebrated as a sign the artificial heart could potentially offer a long-term option for people suffering heart failure. The device is still being trialed and has not yet been approved for general use. BiVACOR's founder, Australian bioengineer Daniel Timms, who invented the device following his father's death from heart disease, said it was 'exhilarating to see decades of work come to fruition.' 'The entire BiVACOR team is deeply grateful to the patient and his family for placing their trust in our Total Artificial Heart,' he said in the statement. 'Their bravery will pave the way for countless more patients to receive this lifesaving technology.' The BiVACOR Total Artificial Heart (TAH) has a single moving part, a levitated rotor that's held in place by magnets. As the name suggests, it's constructed from titanium and there are no valves or mechanical bearings that may be susceptible to wear. It pumps blood to the body and the lungs, replacing both ventricles of a failing heart. Cardiovascular diseases are the leading cause of death globally killing around 18 million people each year, according to the World Health Organization. The long-term ambition is to use the device to save more people who languish on waiting lists for suitable donors. According to the US Health Department, about 3,500 people received heart transplants in 2024. Around 4,400 joined the waiting list the same year. Professor Chris Hayward, from the Victor Chang Cardiac Research Institute, said the BiVACOR heart ushered in 'a whole new ball game for heart transplants.' 'Within the next decade we will see the artificial heart becoming the alternative for patients who are unable to wait for a donor heart or when a donor heart is simply not available,' said Hayward, who is overseeing the Australian patient's recovery and was involved in preparing the device for clinical trials. The device has already been tested in the Food and Drug Administration's Early Feasibility Study in the United States, which saw five patients successfully implanted with the device. Dr. Sanjay Gupta got an exclusive look into a top-secret facility where they genetically modify pigs to be used for human organ donors. The first was last July, when a 58-year-old man suffering end-stage heart failure received the implant during surgery at Texas Medical Center. It kept him alive for eight days until a donor was available. Four other patients followed in the study, which examined the safety and performance of the device, while they waited for a donor transplant. It's hoped the trial will expand to 15 patients. The Australian implant was the first in a series planned by Monash University's Artificial Heart Frontiers Program, a 50 million Australian dollar ($31 million) program to develop and commercialize three devices to treat heart failure. — CNN
Yahoo
12-03-2025
- Health
- Yahoo
Man lives for 100 days with artificial titanium heart in successful new trial
An Australian man lived for 100 days with an artificial titanium heart while he awaited a donor transplant, the longest period to date of someone with the technology. The patient, a man in his 40s who declined to be identified, received the implant during surgery at St. Vincent's Hospital Sydney last November. In February, he became the first person worldwide to leave hospital with the device, which kept him alive until a heart donor became available earlier this month. According to a statement issued Wednesday by St Vincent's Hospital, Monash University and BiVACOR, the US-Australian company behind the device, the man, who had severe heart failure, was 'recovering well.' The ability of the device to sustain him for so long is being celebrated as a sign the artificial heart could potentially offer a long-term option for people suffering heart failure. The device is still being trialed and has not yet been approved for general use. BiVACOR's founder, Australian bioengineer Daniel Timms, who invented the device following his father's death from heart disease, said it was 'exhilarating to see decades of work come to fruition.' 'The entire BiVACOR team is deeply grateful to the patient and his family for placing their trust in our Total Artificial Heart,' he said in the statement. 'Their bravery will pave the way for countless more patients to receive this lifesaving technology.' The BiVACOR Total Artificial Heart (TAH) has a single moving part, a levitated rotor that's held in place by magnets. As the name suggests, it's constructed from titanium and there are no valves or mechanical bearings that may be susceptible to wear. It pumps blood to the body and the lungs, replacing both ventricles of a failing heart. Cardiovascular diseases are the leading cause of death globally killing around 18 million people each year, according to the World Health Organization. The long-term ambition is to use the device to save more people who languish on waiting lists for suitable donors. According to the US Health Department, about 3,500 people received heart transplants in 2024. Around 4,400 joined the waiting list the same year. Professor Chris Hayward, from the Victor Chang Cardiac Research Institute, said the BiVACOR heart ushered in 'a whole new ball game for heart transplants.' 'Within the next decade we will see the artificial heart becoming the alternative for patients who are unable to wait for a donor heart or when a donor heart is simply not available,' said Hayward, who is overseeing the Australian patient's recovery and was involved in preparing the device for clinical trials. The device has already been tested in the Food and Drug Administration's Early Feasibility Study in the United States, which saw five patients successfully implanted with the device. The first was last July, when a 58-year-old man suffering end-stage heart failure received the implant during surgery at Texas Medical Center. It kept him alive for eight days until a donor was available. Four other patients followed in the study, which examined the safety and performance of the device, while they waited for a donor transplant. It's hoped the trial will expand to 15 patients. The Australian implant was the first in a series planned by Monash University's Artificial Heart Frontiers Program, a 50 million Australian dollar ($31 million) program to develop and commercialize three devices to treat heart failure.
