BURLINGTON, Mass.--(BUSINESS WIRE)--Nov 25, 2024--
BrioHealth Solutions, Inc., a developer of world-leading technology in ventricular assist systems, announced today it has enrolled its first patients in the U.S. for the INNOVATE Trial of the BrioVAD ® System.
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“We are thrilled to kick off the INNOVATE trial, following a phenomenal journey of innovation, engineering, and quality refinement to bring the BrioVAD System to life,” said Chen Chen, Ph.D., Chief Executive Officer of BrioHealth Solutions. “Despite advancements in ventricular assist devices, there remains a pressing need for improved device performance and patient outcomes, and BrioHealth is committed to addressing this gap. It is also incredibly rewarding to see the enthusiasm from our participating centers in advancing heart failure treatment through this study.”
BrioHealth has focused on developing its proprietary BrioVAD technology since 2008. The BrioVAD System features the innovative BrioVAD Pump, a fully magnetically suspended blood pump, paired with uniquely engineered external components aimed at reducing adverse events and enhancing patients' quality of life. More than 350 patients outside the U.S. have been treated with a ventricular assist system that incorporates the BrioVAD Pump. *
The INNOVATE trial is a prospective, non-blinded, randomized, controlled, multi-center, non-inferiority study designed to evaluate the safety and effectiveness of the BrioVAD System for treating advanced, refractory left ventricular heart failure.
“Patients with advanced heart failure have limited options when it comes to treatment, with currently just one LVAD system available in the U.S.,” said Francis D. Pagani, M.D., Ph.D., the Otto Gago, M.D., Professor of Cardiac Surgery at University of Michigan Medical School and the study's National Principal Investigator. “Despite treatment advances, complications still occur among LVAD patients. The INNOVATE Trial will provide important insights on if the BrioVAD System can help reduce complications and improve quality of life for patients with advanced heart failure.”
“The initiation of the INNOVATE Trial is an important milestone in advancing treatment options for advanced heart failure patients,” said Mani Daneshmand, M.D., Andrew J. McKelvey Professor, Emory University School of Medicine and Director – Thoracic Transplant and MCS Surgery. “We are excited to learn how the BrioVAD System can make an impact in this patient population.”
About BrioHealth Solutions
BrioHealth Solutions is a medical device company headquartered in Burlington, Massachusetts. It develops, produces, and commercializes devices to treat patients suffering from advanced and persistent heart failure. BrioHealth Solutions is committed to restoring, extending and enhancing the lives of patients globally by collaborating with healthcare providers to push the boundaries of what’s possible and deliver the best medical technologies available. For additional information, please visit the Company's website at www.briohealthsolutions.com and follow the company on LinkedIn and Twitter/X.
About BrioVAD System
The BrioVAD System is a full-support, durable ventricular assist device comprised of an implantable BrioVAD Pump and external components, designed to provide long-term support for heart failure patients. The BrioVAD Pump features an innovative magnetic bearing design that achieves a smaller pump size with a larger impeller, as compared to the only FDA-approved durable ventricular assist system currently available. The compact pump may potentially reduce surgical invasiveness. Additionally, the BrioVAD Pump incorporates a novel driveline design that electrically connects the pump to the external components, resulting in a significantly thinner and more flexible driveline, which may potentially reduce driveline-associated infections.
The combination of the BrioVAD Pump’s magnetic bearing construction and the large diameter impeller facilitates significant innovation in the design of the pump’s blood flow pathway within the pump. This advanced flow path design has the potential to improve device hemocompatibility and hemodynamics, minimizing the risk of serious complications.
The BrioVAD System's external patient worn components incorporate several unique design features, resulting in only two components, which may enhance user experience and patient quality of life.
The BrioVAD System is an Investigational Device limited by Federal Law to use in the INNOVATE Trial.
About the INNOVATE Trial
The INNOVATE Trial is a prospective, non-blinded, randomized, controlled study that will enroll patients for both short-term and long-term Mechanical Circulatory Support indications. For more information, visit www.theinnovatetrial.com
About Advanced Heart Failure
Heart failure is a chronic, progressive disease where the heart muscle loses its ability to pump enough oxygen-rich blood throughout the body. Advanced heart failure is a serious medical condition that refers to the later stages of the disease, and occurs in approximately 650,000, or 10 percent of people with heart failure in the U.S. 1 Approximately 75% of heart failure patients die within five years of diagnosis. 2 As heart failure progresses and the patient enters the later stages of the disease, the use of mechanical circulatory support devices, such as LVADs, may be needed to help the heart effectively pump blood throughout the body and enable the patient to participate in daily activities.
1 American Heart Association (heart.org)
2 Severino, P., Mather, P.J., Pucci, M., et al. (2019). Advanced Heart Failure and End-Stage Heart Failure: Does a Difference Exist. Diagnostics (Basel), 9(4), 170.
*The BrioVAD Pump is the same pump used in the CH-VAD System.
The BrioVAD® System features the innovative BrioVAD Pump, a fully magnetically suspended blood pump, paired with uniquely engineered external components aimed at reducing adverse events and enhancing patients' quality of life. (Graphic: Business Wire)
BEIRUT (AP) — Diplomats and other officials say there have been several sticking points in ceasefire talks to end the war between Israel and the Lebanese militant group Hezbollah, even as conditions for an agreement appear to be ripe.
Israel’s military has killed nearly all of the militant group’s top leaders, but it continues to fire missiles into Israel. Tens of thousands of Israelis who were evacuated from the border months ago are pressuring their government to go home. And the world wants to stop regional conflict from spreading after more than a year of fighting.
Following the latest visit to the region by a U.S. mediator, Israel hit central Beirut over the weekend, and Hezbollah responded with its biggest barrage in weeks as each applied pressure to reach a deal.
Israel and Hezbollah have exchanged fire almost daily since the day after Hamas-led militants attacked Israel on Oct. 7, 2023, setting off the war in Gaza.
Israel launched a widespread bombardment of Lebanon two months ago, then a ground invasion. More than 3,500 people in Lebanon have been killed, many of them civilians.
More than 70 have been killed in Israel, over 40 of them civilians. In addition, over 50 Israeli soldiers have been killed in the ground offensive.
Here’s a look at the proposal and the sticking points.
The proposal under discussion to end the fighting between Israel and Hezbollah calls for an initial two-month ceasefire during which Israeli forces would withdraw from Lebanon and Hezbollah would end its armed presence along the southern border south of the Litani River.
The withdrawals would be accompanied by an influx of thousands more Lebanese army troops, who have been largely sidelined in the war, to patrol the border area along with an existing U.N. peacekeeping force.
An international committee would be set up to monitor implementation of the ceasefire agreement and of U.N. Security Council resolution 1701, which was passed in 2006 to end a monthlong war between Israel and Hezbollah but never fully implemented. Hezbollah never ended its presence in southern Lebanon, while Lebanon said Israel regularly violated its airspace and occupied small patches of its territory.
It is not clear whether a new deal would be any more successfully implemented than the one in 2006.
Michael Herzog, Israel’s ambassador to Washington, told Israeli Army Radio on Monday that the deal aimed to improve surveillance and enforcement of the previous resolution. While he said there were still certain points that needed to be finalized, a deal was close and could be clinched “within days.”
A U.S. official said negotiations continued to progress on Sunday, but the parties still need to work out some outstanding issues to close the deal. The official, who insisted on anonymity to discuss the private talks, declined to detail the outstanding issues.
Two Western diplomats described several points of dispute to The Associated Press, speaking on condition of anonymity because they were not authorized to discuss ongoing negotiations.
They said Israel was asking for more guarantees to ensure that Hezbollah’s weapons are removed from the border area. Israeli officials, concerned about the possibility of Hezbollah launching the kind of attack that Hamas carried out from Gaza into southern Israel, have said they would not agree to a ceasefire deal that doesn't explicitly grant them freedom to strike in Lebanon if they believe Hezbollah is violating it.
An Israeli official, speaking on condition of anonymity because he wasn’t authorized to discuss the sensitive talks, said the issue remained a point of contention, although he said the talks were headed in a “positive direction.”
Lebanese officials have said agreeing to such a deal would violate Lebanon’s sovereignty. Hezbollah leader Naim Kassem has said the militant group would not agree to a deal that does not entail a “complete and comprehensive end to the aggression” and does not protect Lebanon’s sovereignty.
Lebanon and Israel have also disagreed over which countries would sit on the international committee overseeing implementation of the deal and Resolution 1701.
In a sign of progress, Israel appeared to have dropped its opposition to France, which has remained close with Lebanon since its colonial rule there ended and has recently been at odds with Israel.
On Monday, an official familiar with the talks, who spoke on condition of anonymity because they were discussing behind-the-scenes negotiations, said that France would be part of the monitoring committee. Lebanon’s deputy parliament speaker, Elias Bousaab, also said Israel had accepted France.
But Lebanon has refused to allow Britain, a close ally of Israel. It was unclear Monday if Lebanese officials had dropped their opposition following Israel’s concession.
Meanwhile, Israel does not want to enter into negotiations on 13 disputed points along the border as part of a ceasefire deal, the diplomats said.
The European Union’s top diplomat, Josep Borrell, who has a contentious relationship with Israel's government, said Sunday during a visit to Lebanon that he's not convinced that Israel is “interested clearly in reaching an agreement for a ceasefire."
A ceasefire between Israel and Hezbollah, the strongest of Iran's armed proxies, is expected to significantly calm regional tensions that have led to fears of war between Israel and Iran directly. It's not clear how it would affect the Israel-Hamas war in Gaza. Hezbollah had long insisted that it would not agree to a ceasefire until the war in Gaza ends, but it has now dropped that condition.
One diplomat said there are fears that if no ceasefire is reached, the war will expand further into Syria and Iraq as Israel attempts to cut off the supply of weapons from Iran to Hezbollah. Israel has carried out regular airstrikes on Iran-linked groups in Syria and has threatened to strike in Iraq, where Iran-backed militias have periodically launched drone attacks on Israel.
Geir Pedersen, the U.N. special envoy for Syria, said during a visit to Damascus on Sunday that ceasefires in Gaza and Lebanon are critical to “avoid Syria being dragged even further into the conflict.”
Meanwhile, analysts say Hezbollah has been weakened but continues to keep up steady fire into Israel, including strikes far from the border.
On Sunday, Hezbollah fired about 250 rockets and other projectiles into Israel, wounding seven people in one of the militant group’s heaviest barrages in months, in response to deadly Israeli strikes in Beirut. Violent clashes continue in southern Lebanon as Israeli forces attempt to take control of strategic towns.
Israel says its goal in the war with Hezbollah is to enable displaced Israelis to safely return home. In Lebanon, a quarter of the population has been displaced, and parts of the country, particularly in south Lebanon and areas south of the capital Beirut, have been destroyed.
In Lebanon, where officials and residents are anxious for war to end, an initial rush of optimism dissipated after the Biden administration’s point man on Israel and Lebanon, Amos Hochstein, left the region last week without a deal.
Many now believe no agreement will be reached before President-elect Donald Trump takes office in January.
Goldenberg reported from Tel Aviv, Israel. Associated Press writer Aamer Madhani contributed from Washington.
Find more of AP’s war coverage at https://apnews.com/hub/israel-hamas-war
A man walks past a damaged building after a rocket fired from Lebanon hit an area in Rinatya, outskirts of Tel Aviv, Israel, Sunday, Nov. 24, 2024. (AP Photo/Leo Correa)
A member of the Israeli forces inspect a site following a rocket fired from Lebanon hit an area in Rinatya, outskirts of Tel Aviv, Israel, Sunday, Nov. 24, 2024. (AP Photo/Leo Correa)
A Civil Defense worker uses a skid loader to remove the rubble in front of a destroyed building that was hit Sunday night in an Israeli airstrike in Dahiyeh, in the southern suburb of Beirut, Lebanon, Monday, Nov. 25, 2024. (AP Photo/Hussein Malla)
Residents pass in front of a destroyed building that was hit Sunday night in an Israeli airstrike in Dahiyeh, in the southern suburb of Beirut, Lebanon, Monday, Nov. 25, 2024. (AP Photo/Hussein Malla)
A man checks his damaged apartment which was resulted from Sunday's Israeli airstrike in Dahiyeh, in the southern suburb of Beirut, Lebanon, Monday, Nov. 25, 2024. (AP Photo/Hussein Malla)
Israeli soldiers take cover on the side of the road during an alert of incoming rockets, near Kiryat Shmona, northern Israel Sunday Nov. 24, 2024. (AP Photo/Ohad Zwigenberg)
Members of the Israeli forces inspect a site following a rocket fired from Lebanon hit an area in Rinatya, outskirts of Tel Aviv, Israel, Sunday, Nov. 24, 2024. (AP Photo/Leo Correa)
A man stands in front of a destroyed building after Sunday's Israeli airstrike in Dahiyeh, in the southern suburb of Beirut, Lebanon, Monday, Nov. 25, 2024. (AP Photo/Hussein Malla)
Smoke rises after an Israeli airstrike on Dahiyeh, in the southern suburb of Beirut, Lebanon, Monday, Nov. 25, 2024. (AP Photo/Bilal Hussein)