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CroíValve announces the appointment of Jaime Wheeler as Chief Executive Officer. * 4 hrs ago CroíValve, a clinical-stage medical device company developing the DUO(TM) transcatheter tricuspid coaptation valve system, today announced the appointment of Jaime Wheeler, MBA, CPhT, as Chief Executive Officer. In conjunction with this, Lucy O'Keeffe will transition into the role of Chief Operating Officer where she will support Jaime in delivering CroíValve's mission of innovating a better way to treat tricuspid regurgitation (TR). Jaime is a transformational healthcare executive with more than 25 years of experience driving innovation at the intersection of clinical excellence and business strategy. Previously, Jaime served as the Senior Vice President of Global Clinical Affairs, Transcatheter Heart Valves at Edwards Lifesciences. There, she was instrumental in bringing multiple breakthrough therapies to market. Daveigh Chase's cause of death has been revealed Jaime Wheeler, Chief Executive Officer, CroíValve CroíValve recently announced the expansion of its TANDEM II study, a US and EU based prospective, multicenter study to evaluate the safety and performance of the DUO(TM) Adapt System in patients with severe or greater symptomatic TR. Bernard Collins, Chairman of CroíValve, commented: "Jaime brings a proven track record in guiding innovative technologies to market, along with leading high-performing teams. Her leadership will be hugely beneficial in guiding the company through its commercialization journey ahead as we expand our US base and global activities. I would like to thank Lucy, on behalf of the board of directors, for her dedication in leading CroíValve successfully through development and initial clinical validation, demonstrating the value proposition of the DUO System." Jaime Wheeler, newly appointed CEO, commented: "What drew me to CroíValve is the caliber of the team and the strength of the science behind the DUO System. I've built my career on bringing challenging, innovative technologies to patients, and I'm looking forward to doing that here, for our investors and, more importantly, for the patients living with tricuspid regurgitation." Lucy O'Keeffe, newly appointed COO, former CEO and Board member, added: "As CroíValve looks towards commercialization, it is the appropriate time to bring in a leader with the right experience for this next phase. Jaime's exceptional track record of successfully bringing novel transcatheter devices to market is a tremendous asset for CroíValve. I am thrilled to collaborate with her as we embark on this exciting next chapter, accelerating our mission to deliver the DUO System to the patients who need it most." About Jaime Jaime brings more than 25 years of medical device and pharmaceutical leadership, deep clinical research expertise across Cardiology and Structural Heart, and a track record of guiding innovative technologies to market. She has managed multiple divisions and regions, including an expatriate assignment in Tokyo, Japan, and served as clinical lead on multiple successful mergers and acquisitions during her career. She joins CroíValve after 12 years at Edwards Lifesciences, most recently as Senior Vice President of Global Clinical Affairs for the Transcatheter Heart Valve business unit, where she played a pivotal role in advancing the clinical evidence that shapes transcatheter structural heart care today - most notably the PARTNER trial series. Beyond her research leadership, she is a strong advocate for patient access, representation, and health equity, and has held active roles in industry and community leadership. Jaime holds a Bachelor of Science degree from Virginia Tech and a Master of Business Administration from Florida Atlantic University. She is a former Virginia State Emergency Medical Technician (EMT-B) and a Certified Pharmacy Technician (CPhT). She is an active member of AdvaMed, MDEpiNet, MedTech Color, and Girls Inc. of Orange County, among other nonprofit and philanthropic organizations. About CroíValve CroíValve is a clinical stage medical device company focused on the development of a novel transcatheter device for the treatment of tricuspid regurgitation with Research, Development & Operations based in Ireland and Clinical & Regulatory based in the US. Caution: The DUO(TM) System is an investigational device and not for sale in any geography. Media gallery

Edwards Lifesciences settles FTC antitrust charges with $10M penalty over JC Medical deal. The combined $12M penalty (including a $2M penalty to Genesis MedTech) is the largest ever for failing to make an HSR filing. Amanda Pedersen, Senior Editor, MD+DI, Informa Markets - Engineering July 14, 2026 At a glance. * Edwards acquired JC Medical from Genesis MedTech in 2024. * The companies allegedly failed to comply with the requirements of the Hart-Scott-Rodino Act (HSR). * Edwards states that it complied with the requirements of the law. Edwards Lifesciences has been slapped with a $10 million penalty to settle FTC charges. The settlement follows a court ruling that determined the company violated antitrust laws when Edwards acquired JC Medical in August 2024. According to the FTC, the companies involved in the transaction failed to comply with the notification and waiting period requirements of the Hart-Scott-Rodino Act (HSR). Under the proposed final judgement, Edwards had to pay $10 million, and Genesis MedTech, the former owner of JC Medical, had to pay $2 million. The combined $12 million penalty is the largest ever for failing to make an HSR filing, according to the FTC. "Companies that try to sneak deals through without lawful FTC review should take notice," said Chairman Andrew N. Ferguson. "The FTC will be vigilant in enforcing the requirements of the Hart-Scott-Rodino Act, and we will not hesitate to seek penalties for its violation." With the purchase of JC Medical, Edwards acquired the intellectual property and commercial rights to its J-Valve System, a transcatheter aortic valve replacement (TAVR) system for the treatment of severe aortic regurgitation (AR). Edwards made an undisclosed upfront payment for JC Medical and agreed to potential sales-based milestone payments. Genesis MedTech maintained the exclusive right to develop, manufacture, and commercialize the J-Valve System in Greater China. In July 2023, Genesis MedTech completed patient enrollment for a clinical study of the J-Valve transfemoral system for the treatment of aortic regurgitation (J-Valve TF) in China and, in 2024, concluded the one-year patient follow-up. FDA granted a breakthrough device designation for the J-Valve TF in August 2023. The company completed enrollment for an early feasibility study of the J-Valve TF in the United States in February 2024. FDA also gave a nod for JC Medical to initiate its pivotal clinical trial of the device earlier that year. Edwards' statement on the settlement. In a statement provided to MD+DI from Edwards, the company said it does not admit wrongdoing and maintains that it complied with the requirements of the law. "After careful consideration, we believe resolving this with the FTC is the best path forward as we proceed with a clear focus on our mission to innovate for structural heart patients, including those with aortic regurgitation," Edwards stated. AR is a deadly and progressive disease with limited treatment options, and Edwards says it remains committed to leveraging its structural heart knowledge to develop therapies for this underserved patient group by advancing SOJOURN and enrolling patients in the JOURNEY pivotal trial. "We are pleased to be able to conclude this matter so that we can remain focused on our mission and the important work we do for structural heart patients around the world," Edwards stated. According to the FTC complaint, Edwards and Genesis intentionally structured the deal to avoid complying with the HSR Act, which requires parties to submit an HSR form to the federal antitrust agencies and observe a waiting period before completing a transaction. The FTC said the waiting period provides antitrust agencies with time to evaluate the transaction for competitive harm. How Edwards' failed JenaValve acquisition comes into play. In July 2024, Edwards acquired JC Medical without filing under HSR and then attempted to acquire JC Medical's only competitor, JenaValve Technology, the FTC noted. Edwards first announced its intention to buy JenaValve in July 2024. About a year later, FTC challenged the Edwards-JenaValve deal in August 2025. The agency said such a deal would decrease competition in the market for a device that could treat a potentially fatal heart condition. Had the Edwards-JenaValve transaction succeeded, FTC noted, Edwards would have owned the only two companies in the United States with TAVR-AR devices in clinical trials. The FTC sued to block Edwards' acquisition of JenaValve alleging that the deal was anticompetitive and, in January 2026, the U.S. District Court for the District of Columbia granted the FTC's request for a preliminary injunction after a six-day hearing. How did Edwards allegedly dodge HSR review? According to the complaint, Edwards was concerned that HSR review would significantly delay closing on the acquisition of JC Medical, especially in light of its concurrent negotiations to acquire JenaValve. To avoid HSR review, Edwards and Genesis agreed that Edwards would pay $115 million, plus milestone payments, for JC Medical, which fell just below the minimum size-of-transaction threshold of $119.5 million required at the time to trigger HSR review. Edwards, however, also agreed to a contemporaneous $25 million investment in Genesis in connection with the JC Medical acquisition, according to the complaint. In substance, the transactions between Edwards and Genesis met the thresholds for mandatory reporting under HSR, as the combination amounted to more than $119.5 million, the FTC alleged. The final judgement. On top of the monetary penalties, the proposed final judgment also specifies, among other terms, that Edwards will not, without providing advance written notification to the FTC, acquire, directly or indirectly, through subsidiaries or otherwise, any ownership interest, in whole or in part, in any firm that: * Commercially sells a TAVR-AR device in the United States; * Is engaged in clinical trials in the United States for a TAVR-AR device; or * Has received an investigational device exemption from FDA to conduct clinical trials on a TAVR-AR device in the United States. Edwards also will be required to design, maintain, and operate an antitrust compliance program to ensure compliance with the final judgment and the antitrust laws. The FTC vote to accept the settlement and refer the matter to the Department of Justice for filing was 2-0. The Department of Justice filed the complaint and proposed final judgment on the FTC's behalf in the U.S. District Court for the District of Columbia. The entry of the final judgment does not constitute an admission or finding of wrongdoing or liability by any defendant, and defendants deny any wrongdoing or violation of law. Senior Editor, MD+DI, Informa Markets - Engineering Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006. Amanda Pedersen poses with her Jesse H. Neal Awards plaque after winning the "Best Commentary" category with Pedersen's POV After 18 years of reporting on the medical device and diagnostics industry, Amanda has no fear of speaking truth to power. That's important in an industry in which over half of the top 100 companies report more than $1 billion in revenue. In her weekly Pedersen's POV opinion column, she isn't afraid to shine a light on industry leaders for bad behavior. Her insights spark conversation about what price is too high to pay for corporate success in medtech. Amanda graduated from Northern Illinois University in 2003 with a B.A. in Communication. After a few years reporting for community newspapers, including the Galesburg Register Mail in Galesburg, IL, and the Marietta Daily Journal in Marietta, GA, Amanda spent 10 years covering the medical device industry for Medical Device Daily (now known as BioWorld MedTech). Amanda joined the editorial staff of MD+DI in December 2016. Want more MD+DI in your search results? Editors' choice. Jul 24, 2026