Second Heart Assist's Whisper Device Poised to Advance AHA CKM Goals with Breakthrough Heart–Kidney Support
'The industry has been forced to choose between protecting the heart or the kidney. Whisper proves you can, and must, do both'— Jeff Donofrio, CEO- Second Heart Assist
SALT LAKE CITY, CA, UNITED STATES, August 15, 2025 / EINPresswire.com / -- Second Heart Assist, Inc. is introducing its Whisper percutaneous mechanical circulatory support device as a potential new force in the fight against cardiovascular–kidney–metabolic (CKM) disease. Whisper is designed to enhance kidney perfusion while unloading the heart, supported by low hemolysis results in FDA-requested bench testing.
The American Heart Association (AHA) has declared CKM syndrome a public health emergency, with only 10% of U.S. adults meeting 'excellent' CKM health standards. As the AHA expands its CKM initiative to 15 regions and 150 care sites, it is calling for earlier screening and integrated treatment that unites cardiology, nephrology, and metabolic care.
Whisper's dual-organ approach was built to align with that vision.
Performance that benefits both heart and kidney
Many older-generation devices require extremely high rotational speeds to increase kidney flow, which can also raise red blood cell damage (hemolysis). Whisper is engineered for low-RPM performance and placed in the descending aorta just above the renal arteries. This position directs blood where the kidneys need it most while easing the heart's workload.
'The industry has been forced to choose between protecting the heart or the kidney. Whisper proves you can, and must, do both,' said Jeff Donofrio, CEO of Second Heart Assist. 'We have seen it in our international results and in our hemolysis data. Our focus is on delivering solutions that are fast to deploy, safe for patients, and effective where it matters most.'
Company-reported OUS results
• 28 patients treated outside the United States
• No device-related adverse events
• Average hospital stay of 48 hours
• Zero readmissions during the initial follow-up period
• Average deployment and initiation of treatment in under 2 minutes
Hemolysis advantage
In an FDA-requested in vitro study, Whisper showed approximately 50% less mechanical hemolysis than a comparator device (Impella) under identical conditions, operating at about 10,000 RPM versus more than 44,000 RPM required by the comparator to match flow.
Expert perspectives
Leslie W. Miller, MD, Chief Medical Officer, Second Heart Assist
'The CKM initiative will bring needed attention to the important dynamic interaction between the heart and kidney as heart failure triggers adverse responses in the kidneys that secondarily worsens kidney function and patients with intrinsic kidney impairment have a high incidence of secondary cardiac disease. The positioning of the SHA device provides simultaneous benefit to both the heart and kidneys by unloading the heart to increase cardiac output, and significantly increasing blood flow to the kidney to reverse the consequences of heart failure and stimulate the recovery of the function of both organs.
Rob Coronado, MD, Advisor, Second Heart Assist
'For patients with vulnerable kidneys, every moment of optimized perfusion matters. Whisper reflects the priorities of CKM care. It supports kidney health, protect the heart, and make the therapy simple, safe, and fast to deliver.'
Why this matters
Heart failure readmissions remain among the most frequent and costly events in U.S. healthcare and are often linked to kidney decline. The AHA's CKM initiative emphasizes strategies that protect both organs to reduce complications, improve patient outcomes, and lower costs. Whisper's engineering and early results position it as a powerful candidate for this integrated approach.
Next steps
Second Heart Assist is preparing to launch its U.S. Early Feasibility Study, building on OUS experience and published bench data, with the goal of helping health systems deliver on AHA CKM objectives in real-world care.
About Second Heart Assist
Second Heart Assist develops percutaneous and implantable circulatory support systems intended to improve hemodynamics while addressing kidney-relevant flow needs. The company's U.S. patent portfolio includes U.S. Patent No. 11,602,627 and related international applications covering stent-cage pump configurations and renal-adjacent positioning concepts.
Adam Steelwater
Innovative Tech Capital Network
email us here
Legal Disclaimer:
EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
6 hours ago
- Yahoo
It's been a long road, but Blood Oxygen tracking is back for the newest Apple Watches in the US – but the feature isn't the same
When you buy through links on our articles, Future and its syndication partners may earn a commission. Following an 18-month ban, Blood Oxygen tracking is coming back to the Apple Watch Series 9, Series 10, and Ultra 2 It's not an entirely on-device experience anymore, though The Apple Watch still measures Blood Oxygen, but the iPhone will calculate and display the final result It's been a long 18 months, but Apple's announced that Blood Oxygen tracking and monitoring are returning to the Apple Watch Series 9, Series 10, and Ultra 2 in the United States. The feature was disabled and effectively banned on the Series 9 and Ultra 2 – then the Series 10, which launched later – after a ruling in January 2024 due to a patent dispute over the technology being used between Massimo and Apple. Now, thanks to iOS 18.6.1 and watchOS 11.6.1, which will roll out later today, the feature is returning in a 'redesigned' form. In its new iteration, the Apple Watch Series 9, Series 10, and Ultra 2's sensors can take a reading, then transmit the data to the connected iPhone, where it will be calculated and displayed in the Health app under 'Respiratory' readings. So no, you won't be able to take the reading, watch as it progresses, and then view the results right on your wrist, as you could before. Still, this does effectively return the tracking and monitoring functionality to the impacted Apple Watch models in the United States. In a statement shared, Apple explains the changes as: 'Users with these models in the U.S. who currently do not have the Blood Oxygen feature will have access to the redesigned Blood Oxygen feature by updating their paired iPhone to iOS 18.6.1, and their Apple Watch to watchOS 11.6.1. Following this update, sensor data from the Blood Oxygen app on Apple Watch will be measured and calculated on the paired iPhone, and results can be viewed in the Respiratory section of the Health app. This update was enabled by a recent U.S. Customs ruling.' The U.S. Customs ruling is key here, as this will return the feature to the Apple Watches sold when the ban began and was subsequently enforced. If you still have an older Apple Watch, or one sold prior to January 2024, the Blood Oxygen functionality remains unimpacted and won't be changed. That also goes for any models sold outside of the United States, which have been unimpacted by this ruling. Still, this does return the Blood Oxygen feature to the Apple Watch, even if it splits the experience between watch and phone. But this separation is likely key to having this allowed and approved by U.S. Customs. For those who have purchased an Apple Watch Series 9, 10, or Ultra 2 in those many months, this is a return to form and rounding out of the health tracking features on Apple's star wearable in the United States. Even in our Apple Watch Series 10 review, we noted that the Blood Oxygen tracking feature was missing in the US. Apple has a pretty smart rollout here, and considering rumors of further pushes into health features that we might see with future generations of Apple Watch models, it might be helpful to have these readings going straight into the Health app. Either route, though, if you've been waiting for Blood Oxygen tracking to return, it's back, but you'll want to make sure your iPhone is nearby if you want to see the results. While Apple has not shared an exact timing for the rollouts of iOS 18.6.1 and watchOS 11.6.1, it has promised to arrive today – August 14, 2025 – in the United States, and we'll update this piece when we see it rolling out. You might also like Constantly dismissing notifications on your Apple Watch? You're going to love Apple's watchOS 26 latest gesture I'm a fitness tracker expert, and here are my top 3 subscription-free picks for 2025 Garmin Venu X1 review: The most innovative Garmin watch in years, and a genuine Apple Watch Ultra rival
Yahoo
9 hours ago
- Yahoo
After heart surgery, flag football champ Sophie Guitron is chasing L.A. Olympics bid
At age 10, Sophie Guitron began to suspect that something was wrong. For two weeks, her high fever and rashes did not respond to any treatment. 'I went to the hospital and they couldn't find what was wrong with me. I had very high fevers, rashes all over my body and nothing controlled the symptoms,' Guitron recalled. She was initially diagnosed with arthritis, but after a series of tests, doctors detected something much more serious: a rare congenital heart disease that required open-heart surgery. 'The final diagnosis was systemic juvenile idiopathic arthritis. Instead of my joints becoming inflamed, my organs were inflamed, and that's how they discovered the heart disease I was born with,' explained the Mira Costa High graduate. Guitron was born with an anomaly in the aortic portion of the left coronary artery, an extremely rare condition. Read more: L.A. names coveted five provisional sports it wants to add for 2028 Olympics Her father, José, recalls that despite the pain, his daughter never lost her composure. 'She has always had a very high pain tolerance,' he said. In August 2018, Sophie Guitron underwent successful surgery at Stanford Hospital in Palo Alto. Although her recovery was long and emotionally difficult, especially because she couldn't immediately return to soccer, her sport since the age of 6, that moment marked the beginning of a new chapter. During school breaks, while watching her classmates play flag football, something awakened in her. She learned the rules, decided to give it a try and fell in love with this new sport. She joined a recreational team and won a championship in a local league, as well as the respect of her teammates, being the only girl on the team. The title was especially meaningful: Guitron scored the winning touchdown and was named most valuable player of the tournament. With her passion for this new sport growing, she joined a co-ed club where she continued to develop. In high school, she realized that Mira Costa did not have a women's team. So she wrote directly to the Chargers for help. The NFL franchise responded by sponsoring the creation of the first women's flag football team in the school's history. The effort paid off. During her senior year, Guitron and Mira Costa won the Bay League championship and achieved the school's first playoff victory. Playing various positions, but excelling mainly as a wide receiver, Guitron was recognized as the league's most valuable player and received Division 2 All-CIF honors. Her development was partly thanks to the Conquer Chargers club in Irvine. Her parents supported her by driving her to practice, a trip that took more than an hour each way to and from Orange County. Guitron's Conquer Chargers coach, Justin Schulman, highlighted not only her skill but also her mindset: 'She knew what she wanted, she sought us out on social media, and she earned her spot. She's a very talented runner, but above all, she's determined.' In 2024, she represented the United States in the Junior International Flag Football Cup, winning the gold medal against teams from Canada, Japan, Panama and Mexico. Her growth did not go unnoticed. The NFL recently chose her to be part of the 'Chase Something' campaign, alongside quarterback Jayden Daniels and Olympic gymnast Jordan Chiles. The campaign urges young athletes to pursue their dreams. She had previously been awarded the NFL Latino Youth Honors 2024 in New Orleans, an event that celebrates Latino seniors with athletic and academic achievements. With a 4.2 GPA and nominated by the Rams, she received $25,000 for her college education. Guitron, 18, will play flag football for Keiser University in Florida, alongside other emerging stars of the sport such as Janasia Wilson and Ashlea Klam. She plans to study sports management and has already represented the United States at the U17 level. But her biggest dream is clear: to make it to the 2028 Los Angeles Olympics, where flag football will make its debut in the Olympic program. 'I'm working very hard to be at the 2028 Games, but my career won't end there. I'm young and I also want to make it to the 2032 Olympics,' said Guitron, who is 5-foot-5. Schulman, Guitron's coach, says there is no doubt that she will succeed. 'She is so dedicated to the sport," he said. "... I've already asked her to save me tickets to see her in Los Angeles.' With deep Latino roots, the daughter of Lilia, born in Mexico, and José, a Californian with Mexican parents, Guitron is also aware she is a role model. 'I am proud to be American, but also Mexican American. It is an honor to represent Latinas in sports. I love being that person,' Guitron said. Her father agrees: 'I remind her that she is a pioneer. She is part of a movement that, in the future, will be history.' Although her arthritis is still present, in remission but with occasional flares of pain, Guitron believes that her experiences have made her stronger. 'I am very grateful for everything I have been through, even though it has been difficult," Guitron said. "It has made me who I am." This article first appeared in Spanish via L.A. Times en Español. Get the best, most interesting and strangest stories of the day from the L.A. sports scene and beyond from our newsletter The Sports Report. This story originally appeared in Los Angeles Times.
Yahoo
10 hours ago
- Yahoo
1 Beaten-Down Stock That Could Soar by the End of the Year
Key Points Viking's leading weight management candidate is being investigated in two formulations. The stock could soar later this year, provided the oral version aces phase 2 studies. Viking Therapeutics is somewhat risky, but it also has significant upside potential. 10 stocks we like better than Viking Therapeutics › Some smaller drugmakers choose to develop medicines for diseases for which there are no therapeutic options. This allows them to avoid direct competition from larger pharmaceutical companies. That's not exactly the strategy Viking Therapeutics (NASDAQ: VKTX) chose. The mid-cap biotech is working on weight loss therapies, an increasingly competitive market dominated by Eli Lilly (NYSE: LLY) and Novo Nordisk, as well as numerous other well-established players in the industry seeking to enter the space. Going up against these giants is no small challenge, but Viking is, so far, holding its own. And if it can play its cards right, its stock could soar by the end of the year and go on to generate strong returns from then on out. Here's more on Viking Therapeutics. Eli Lilly's setback creates an opportunity Viking Therapeutics' shares soared last year following the release of strong phase 2 data for its subcutaneous weight management candidate, VK2735. The stock has declined significantly since that milestone, although it's not due to anything Viking did wrong. Broader market volatility, combined with long-term shareholders taking some profits, is likely responsible for the stock's 40% drop over the trailing-12-month period. VK2735 is currently in phase 3 studies, but Viking is also developing an oral version of the medicine, which is in phase 2 clinical trials. There is a race to develop a highly effective oral GLP-1 anti-obesity therapy, since the current market leaders are administered via subcutaneous injection. If Viking Therapeutics' oral candidate can impress in mid-stage studies, the stock could soar. That's especially the case since Eli Lilly's investigational oral GLP-1 medicine, orforglipron, failed to perform as well as expected in a phase 3 study in obese or overweight patients who didn't have diabetes. Orforglipron led to a mean weight loss of 12.4% in a 72-week study, which wasn't as impressive as the market wanted. This result paled in comparison to Lilly's injectable Zepbound, which led to an average weight loss of 20.2% in a phase 3 study. Viking Therapeutics' shares jumped on the pharmaceutical giant's bad news, but there's plenty of upside left if its oral weight loss candidate meets Wall Street's expectations. It's best to start small Eli Lilly is perceived as the leader in the weight management market. The company's continued dominance in this field was likely somewhat baked into investor expectations, requiring it to deliver outstanding clinical trial results to justify its share price. Viking is a much smaller drugmaker than Lilly, so the market will likely have lower expectations for its data readouts for VK2735. Viking also has several other exciting candidates. The company is working on a drug called VK2809, a potential therapy for metabolic dysfunction-associated steatohepatitis (MASH), which produced solid results in phase 2 studies. There is a vast unmet need in MASH, considering several million people have the disease, yet the U.S. Food and Drug Administration has approved just a single medication for it. Elsewhere, Viking has a next-gen anti-obesity candidate that could soon start human clinical trials. The company has a lot going on, and if VK2735-related developments remain strong through the end of the year, the stock could soar. However, Viking -- like any clinical-stage biotech company -- is a somewhat risky bet. On the one hand, it has generated strong mid-stage data for two separate medicines that address high unmet needs. Its leading candidate, VK2735, has the potential to become a blockbuster; that's impressive. Even so, the stock will plummet if VK2735 encounters clinical setbacks. So, should you buy shares? In my view, it depends on your level of risk tolerance. Risk-averse investors should look elsewhere. If you're comfortable with a bit of volatility, you should seriously consider the stock; however, it would be wise to start by initiating a small position. If the data from the ongoing phase 2 study for oral VK2735 is good, it might be worth adding even more shares thereafter. Should you buy stock in Viking Therapeutics right now? Before you buy stock in Viking Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Viking Therapeutics wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $668,155!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,106,071!* Now, it's worth noting Stock Advisor's total average return is 1,070% — a market-crushing outperformance compared to 184% for the S&P 500. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of August 13, 2025 Prosper Junior Bakiny has positions in Eli Lilly, Novo Nordisk, and Viking Therapeutics. The Motley Fool recommends Novo Nordisk and Viking Therapeutics. The Motley Fool has a disclosure policy. 1 Beaten-Down Stock That Could Soar by the End of the Year was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
