KIRKLAND, Wash.--(BUSINESS WIRE)--Jul 8, 2026--
Cardiac Dimensions, a leader in transcatheter therapies for heart failure, today announced the publication of three major manuscripts that together form the most comprehensive evidence base ever assembled for transcatheter indirect mitral annuloplasty. These publications span a five-year multi-center commercial registry, the largest single-center experience across both preserved and reduced ejection fraction, and long-term survival results through ten years.
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The Carillon Mitral Contour System is the only commercially available indirect mitral annuloplasty device, designed to treat a broad and expanding population of patients living with functional mitral regurgitation. The newly published data further strengthen the clinical foundation for the therapy as Cardiac Dimensions advances toward regulatory submissions in the United States and continues to expand its commercial presence in Europe.
“Heart failure clinicians are looking for therapies that are safe, effective, and durable in real-world practice. The five-year CINCH FMR registry results stand out because they demonstrate sustained reduction in mitral regurgitation, sustained improvement in symptoms, and an excellent safety profile across a broad patient population,” said Dr. William T. Abraham, Chief Medical Officer of Cardiac Dimensions. “These results matter clinically because they reflect everyday practice rather than highly selected trial populations. The consistency of benefit in both HFrEF and HFpEF is especially meaningful. Together, these data show that the Carillon therapy has matured into a proven and reliable option for patients with functional mitral regurgitation.”
Three Publications Spanning Durability, Real-World Performance, and Broad Patient Inclusion
1. Five-Year Multi-Center Real-World Outcomes from the CINCH FMR Registry (228 Patients)
The CINCH FMR registry is the largest multi-center dataset evaluating indirect mitral annuloplasty in contemporary practice. Key findings include:
2. Largest Single-Center Analysis Highlights Effectiveness Across Both HFrEF and HFpEF (204 Patients)
This single-center experience provides important insight into patient groups historically underrepresented in clinical trials. Key findings include:
3. Ten-Year Cardiovascular Survival After Indirect Mitral Annuloplasty
A single-center extension of the REDUCE FMR trial provides the longest known follow-up for any transcatheter mitral repair therapy.
“These three publications build on our extensive and growing body of evidence and represent a significant step forward for the Carillon therapy and for the field of transcatheter mitral repair,” said Rick Wypych, President and CEO of Cardiac Dimensions. “With a robust and consistent dataset now spanning multiple studies, we are energized as we advance toward U.S. approval through the EMPOWER Trial and accelerate our global commercial growth.”
The Carillon Mitral Contour System has CE Mark and is available for sale in Europe and other countries that recognize CE Mark.
About the Carillon Mitral Contour System
The Carillon Mitral Contour System is a minimally invasive device designed to treat heart failure patients with functional mitral regurgitation by reshaping the mitral valve apparatus via the coronary sinus. It is commercially available in Europe, as well as other countries, and is currently being studied in the U.S. pivotal EMPOWER Trial.
About the EMPOWER Trial
The EMPOWER Trial is a prospective, randomized, sham-controlled pivotal study evaluating the safety and effectiveness of the Carillon Mitral Contour System® in heart failure patients with mild to severe functional mitral regurgitation. Designed to enroll up to 300 patients across leading U.S. and international centers, the trial aims to support FDA approval by demonstrating the Carillon therapy’s potential to improve symptoms, cardiac structure, and long-term outcomes in a broad heart failure population.
About Cardiac Dimensions
Cardiac Dimensions is committed to addressing the rapidly growing patient population suffering from heart failure with functional mitral regurgitation. With decades of clinical experience and thousands of patients treated worldwide, the company’s Carillon device is uniquely positioned as a durable therapy designed to treat early and late-stage patients, improve symptoms and reverse disease progression. Learn more at www.cardiacdimensions.com.
CAUTION: In the United States, the Carillon Mitral Contour System is an investigational device, limited by federal law to investigational use.
Carillon Mitral Contour System®
LONDON (AP) — Nigel Farage says the political establishment is out to stop him. But the Reform UK leader’s attempt to prove it has not gone to plan.
Facing awkward questions about his finances, the anti-immigration politician dramatically announced that he’s quitting Parliament in order to run again, a move critics denounced as a ploy to dodge a parliamentary probe. His resignation as a lawmaker became official on Wednesday.
Farage said the special election will be “people versus the establishment.” But his opponents aren't playing ball. All the major political parties say they will not field candidates against Farage, leaving him to run all but unopposed.
The gambit could backfire further if an investigation into his finances continues and creates a scenario requiring a second special election.
Here’s what to know about a dramatic development in British politics and what comes next.
Farage only became a British lawmaker two years ago, winning election to Parliament after seven failed attempts, and has led a series of fractious hard-right political parties. But he is arguably one of the most influential politicians of recent decades.
His obsession with taking the United Kingdom out of the European Union helped turn Brexit from a fringe cause to a reality. More recently, he has tapped into anxieties about immigration and social change in a way that echoes his ally, U.S. President Donald Trump, and European populists.
Farage has capitalized on — critics say stoked — concerns about migrants crossing the English Channel in small boats, which he has called an invasion, and alleges that white people face discrimination from police.
Reform UK holds just eight of the 650 seats in the House of Commons, but consistently leads opinion polls and was the big winner in local and regional elections in May that led to the ouster of Prime Minister Keir Starmer at the hands of his own Labour Party.
If the pattern holds, Farage could become prime minister after the next election, due by 2029.
Farage has many sources of income other than a lawmaker’s salary, including hawking gold bullion, hosting a TV current affairs show, public speaking and recording personal video messages on the Cameo website.
Parliament’s standards watchdog is investigating a potentially rule-breaking donation of 5 million pounds ($6.7 million) from Christopher Harborne, a Thailand-based cryptocurrency billionaire. Farage says the money was a personal gift he used to fund his personal security and came before he was elected to the House of Commons. Newly elected lawmakers must declare gifts worth more than 300 pounds ($400) received in the previous 12 months if they are related to political activities.
Farage is also facing questions about his financial relationship with George Cottrell, an aristocratic crypto-gambling entrepreneur who served a U.S. prison sentence for fraud.
A finding of wrongdoing could lead to Farage being suspended from Parliament, which in turn could trigger a special election for his seaside seat of Clacton in eastern England.
Rather than await the outcome, Farage made the first move by triggering an election himself.
But if Farage wins, as seems highly likely, the standards inquiry is set to resume. If it finds Farage broke the rules, there could be another Clacton election within months.
Farage has said he is frustrated and fed up with politics. He has a history of walking away from parties he led. He stepped down from both the UK Independence Party and its successor, the Brexit Party, in the last decade.
Tim Bale, professor of politics at Queen Mary University of London, says he suspects Farage will stay put to lead Reform into the next election.
“Fighting and winning a by-election is perhaps his best hope of suggesting to people that he is still very much a man alone, fighting the establishment,” Bale said.
Farage insists he has “done nothing wrong” and is the victim of dirty tricks by his political foes and “constant demonization” by the media.
Bale said the snap election allows him to distract attention away from allegations about his finances. But he said Farage risks being seen “as a self-pitying, angry guy on an ego trip who is determined to distract people from some awkward facts.”
Opponents called the move a stunt and a sign Farage is on the ropes. Reform UK has lost three consecutive special elections that it hoped to win, a possible sign its support may be sagging. The most recent loss was to Labour’s Andy Burnham, who is all but certain to succeed Starmer as prime minister within weeks.
Labour, the Conservatives, the Liberal Democrats and the Green Party all said they would not run against Farage.
“He’s run himself into a cul-de-sac and it was a stunt," Starmer said Wednesday. The prime minister said Farage is "up to his neck in sleaze and he doesn’t want to answer questions about it.”
So far only one candidate has announced plans to run against Farage: Count Binface, a comedian with a trash can on his head.
Jon Harvey is the man under the can, a self-described 5,000-year-old intergalactic space warrior who is a perennial candidate with no expectation of winning in the U.K.'s highest-profile elections. He has run against former Conservative Prime Ministers Boris Johnson and Rishi Sunak, London Mayor Sadiq Khan and, most recently, Burnham.
Dressed like a character in a low-budget sci-fi film, Binface offers offbeat policies catering to locals, such as synchronizing traffic lights on a particularly busy street or moving the hand dryer in the Crown & Treaty Pub in Uxbridge “to a more sensible location.” A standing pledge is to cap croissant prices at 1.10 pounds ($1.47).
Binface told the BBC on Wednesday that his main appeal in Clacton would be that "I’m not Nigel Farage.” He said the lack of other candidates said more about them than him.
“Are they running scared from old Binny, or do they think that Nigel’s running a cunning stunt?" he said.
Britain's Reform UK leader Nigel Farage leaves Milbank Tower after he said he'll quit his Parliament seat and seek reelection in London, Tuesday, July 7, 2026.(AP Photo/Thomas Krych)
FILE - Independent candidate Count Binface speaks to a journalist as he arrives for the vote count in Britain's general election at the Richmond and Northallerton count center in Northallerton, England, Friday July 5, 2024. (Temilade Adelaja, Pool via AP, file)
Britain's Reform UK leader Nigel Farage leaves Milbank Tower after he said he'll quit his Parliament seat and seek reelection in London, Tuesday, July 7, 2026.(AP Photo/Thomas Krych)
