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FDA clears device to fix leaky heart valves. By Salsabila Hartanti October 30, 2026 Abbott announced Wednesday that the FDA cleared its Amplatzer Paraclose PVL Occluder, marking the first U.S. approval for a catheter-based solution to seal leaks forming between heart tissue and surgically implanted replacement valves. The device treats paravalvular leak after valve replacement surgery, sparing patients from another open-heart surgery. Paravalvular leaks occur in 7% to 17% of mitral valve replacements and 5% to 10% of aortic valve replacements, causing symptoms such as shortness of breath and swelling of the legs and feet. The Amplatzer Paraclose PVL Occluder is the first minimally invasive device approved in the U.S. to close these leaks, offering an alternative to additional open-heart surgery. Sandra Lesenfants, senior vice president of Abbott's structural heart business, states that the device fills a critical unmet need, allowing many patients to avoid the risks of another surgery. FDA approval was supported by positive clinical data from the PARADIGM trial, a prospective, multicenter, single-arm study of 200 patients, which showed the device is an effective, minimally invasive alternative to repeat open-heart surgery. Abbott will present 30-day results from the trial at the upcoming Transcatheter Cardiovascular Therapeutics conference in San Diego. The Amplatzer Paraclose device is the latest addition to Abbott's portfolio of minimally invasive Amplatzer devices, including the Piccolo Occluder and Talisman PFO Occluder. Outside of the U.S., the device has been approved to treat paravalvular leaks in Europe since 2020, where it is known as the Amplatzer Valvular Plug III.

Another global medical device giant has officially announced its spin-off! October 26, 2026 Source: drugdu 43 According to recent foreign media reports, Abbott announced the spin-off of its businesses and a downward revision of its full-year guidance after releasing its Q3 results. Abbott announced plans to spin off its nutrition business into an independent company by the end of 2027. The new independent company will have annual sales of $8.5 billion, 16,000 employees, and 14 manufacturing sites. Its product portfolio will include well-known brands such as Ensure (a nutritional supplement drink), PediaSure (a pediatric nutritional supplement), Glucerna (a diabetes management nutrition brand), and Similac (an infant formula brand). Daniel Salvadori, the current Executive Vice President and Group President of Mature Pharmaceuticals and Nutrition Products, will become the CEO of this independent company. The spin-off plan includes Abbott distributing shares of the independent nutrition company to Abbott shareholders. Upon completion of the spin-off, Abbott shareholders will hold shares in both Abbott and the independent nutrition company. It is worth mentioning that before the spin-off plan was announced, Abbott had already reached settlement agreements worth more than $1 billion in lawsuits related to its infant formula products - of which $670 million was used to settle 2,000 claims and nearly $385 million was used to resolve charges related to the U.S. Department of Justice's False Declarations Act. However, the spin-offs by these giants are not a contraction, but a refocusing. Undoubtedly, they are divesting non-core, low-growth segments, channeling the resulting cash flow and organizational energy into higher-certainty battlegrounds. Abbott is no exception. After the spin-off, Abbott will focus on its core high-growth, innovation-driven portfolio of medical devices, diagnostics, and established pharmaceuticals. The spun-off nutrition business can also operate as an independent company, allowing for better allocation of strategic resources and a focus on priorities. Looking at Abbott's Q3 results, the spin-off plan has become clearer. In Q3, Abbott achieved revenue of $13.013 billion (+14.5%) and net profit of $920 million, a year-on-year decrease of 44.01%. Within Abbott's business segments, medical devices and established pharmaceuticals are the two main revenue drivers. In Q3, medical device sales grew 6.9% to $5.826 billion. Electrophysiology and cardiac rhythm management saw significant growth, both achieving double-digit increases. However, the nutrition business experienced slower growth and smaller scale compared to other segments, with revenue of $2.262 billion this quarter, representing a year-over-year increase of only 5.1%. At the same time, Abbott lowered its full-year guidance to comparable sales growth of 6.0% and earnings per share of $5.50 to $5.55, down from its previous guidance of sales growth of 6.5% to 7.5% and earnings per share of $5.45 to $5.60. It's worth noting that global medical device giants have frequently spun off their businesses in recent years. Following Medtronic's spin-off of MiniMed and Johnson & Johnson's proposed spin-off of its orthopedic business, DePuy Synthes, Abbott also officially announced the spin-off of its nutrition business into an independent company. Furthermore, business restructuring has been frequently occurring in the past two years. GE Healthcare integrated its imaging business and advanced visualization solutions into the "Advanced Imaging Solutions (AIS)" segment, while simultaneously promoting Patient Care Solutions (PCS) to improve profitability and evaluate its strategic options. Boston Scientific has launched a new round of global restructuring, involving supply chain optimization, production line relocation, and organizational restructuring, which is expected to be largely completed by the end of 2029. Source: https://news.yaozh.com/archive/49226.html