Latest news with #Tendyne
Yahoo
29-05-2025
- Business
- Yahoo
Abbott Gains FDA Approval for Tendyne™, Strengthening Its Minimally Invasive Heart Portfolio
Abbott Laboratories (NYSE:ABT) has received FDA approval today for its Tendyne™ transcatheter mitral valve replacement (TMVR) system, the first device of its kind approved in the US to treat mitral valve disease without open-heart surgery. Tendyne is specifically designed for patients who are not suitable candidates for surgical valve repair or replacement. The product perfectly fits the aging population trends and the demand for less invasive treatments, implying that it could become a significant cash cow for ABT. An operating room with a doctor monitoring a patient's vital signs during surgery with a medical device. The approval gives Abbott Laboratories (NYSE:ABT) a competitive edge in the growing structural heart market, valued at around $15 billion globally, and will likely accelerate the company's growth. The Medical Devices segment accounts for 47% of total revenue in Q1 2025 and is the fastest growing segment - the US revenues posted 15% growth YoY, meaning that the segment is already central to the growth story. The announcement comes weeks after ABT reiterated its organic revenue growth guidance at 7.5% to 8.5% for FY2025, while the street consensus expects only 6.4% total revenue growth. This raises the odds of positive surprises later in the year, which could propel ABT shares even higher. For reference, ABT already outperforms the broad market by a massive 17% year-to-date, highlighting its strong momentum. Abbott Laboratories (NYSE:ABT) is a global healthcare company that owns a portfolio of life-changing technologies across diagnostics, medical devices, nutritionals, and branded generic medicines. While we acknowledge the potential of ABT as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than ABT and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: and Disclosure: None.
Yahoo
29-05-2025
- Business
- Yahoo
Abbott Stock Gains Following FDA Approval of the Tendyne System
Abbott Laboratories ABT has recently received Food and Drug Administration ('FDA') approval for its Tendyne transcatheter mitral valve replacement ('TMVR') system. The Tendyne system replaces mitral valves that are not functioning properly due to severe mitral annular calcification ('MAC'). The Tendyne system expands the company's comprehensive Structural Heart portfolio. After the announcement, Abbott shares edged up 1.3%, finishing at $132.94 yesterday. The company's Structural Heart arm benefits from a unique range of product portfolio, which includes MitraClip, a mitral valve transcatheter edge-to-edge repair system, and TriClip, a tricuspid valve transcatheter edge-to-edge repair system. The portfolio also contains transcatheter aortic heart valves — Portico and Navitor. Hence, we expect the market sentiment toward ABT stock to remain positive surrounding the latest development. Abbott holds a market capitalization of $231.29 billion. The company's earnings yield of 3.9% surpasses the industry's 0.6%. ABT delivered an average earnings beat of 1.6% in the trailing four quarters. MAC stiffens the structure of the mitral valve and can lead to mitral regurgitation or stenosis that disrupts the heart's ability to pump blood effectively. The complex nature of this mitral valve disease and patients' specific needs and health conditions can pose challenges for surgical correction. The Tendyne system offers an alternative, minimally invasive way to replace the valve of patients with severe MAC who are at high risk for open-heart surgery. The innovative and unique design of the Tendyne system and the valve's availability in multiple sizes allow it to adapt to a range of patient anatomies. The self-expanding valve is delivered through a small incision in the chest and then advanced into the heart to replace the mitral valve. The valve is fully repositionable and retrievable during implantation, allowing for the best possible outcome for people requiring a valve replacement. Image Source: Zacks Investment Research Per Medi-Tech Insights' report, the TMVR market is projected to witness a compound annual growth rate of 20% from 2025 to 2030. Key factors driving growth are increased prevalence of mitral valve diseases, growing preferences for minimally invasive procedures and expanding geriatric population. Earlier this month, Abbott unveiled results from its REFLECT real-world studies, conducted using data from the comprehensive Swedish National Diabetes Register. The findings revealed that the company's FreeStyle Libre continuous glucose monitoring (CGM) technology helps significantly reduce the risk of hospitalization for heart complications in people with diabetes. Over the past year, Abbott's shares have risen 32%, surpassing the industry's 10.3% growth. Abbott currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader medical space are Phibro Animal Health PAHC, AngioDynamics ANGO and STERIS STE. PAHC carries a Zacks Rank #1 (Strong Buy) at present. It has an estimated long-term earnings growth rate of 26.2% compared with the industry's 15.9%. You can see the complete list of today's Zacks #1 Rank stocks here. Its earnings surpassed the Zacks Consensus Estimate in each of the trailing four quarters, the average surprise being 30.6%. Its shares have rallied 26.3% compared with the industry's 10% growth in the past year. AngioDynamics, carrying a Zacks Rank #1 at present, has an estimated earnings growth rate of 23.7% for 2025. ANGO's earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 70.85%. ANGO's shares have risen 49.2% in the past year compared with the industry's 5.5% growth. STERIS, carrying a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 10.8% for 2025. STE's earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 0.61%. Its shares have risen 34.1% compared with the industry's 7.7% growth in the past year. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Abbott Laboratories (ABT) : Free Stock Analysis Report AngioDynamics, Inc. (ANGO) : Free Stock Analysis Report STERIS plc (STE) : Free Stock Analysis Report Phibro Animal Health Corporation (PAHC) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Yahoo
28-05-2025
- Business
- Yahoo
Abbott Stock Gains Following FDA Approval of the Tendyne System
Abbott Laboratories ABT has recently received Food and Drug Administration ('FDA') approval for its Tendyne transcatheter mitral valve replacement ('TMVR') system. The Tendyne system replaces mitral valves that are not functioning properly due to severe mitral annular calcification ('MAC'). The Tendyne system expands the company's comprehensive Structural Heart portfolio. After the announcement, Abbott shares edged up 1.3%, finishing at $132.94 yesterday. The company's Structural Heart arm benefits from a unique range of product portfolio, which includes MitraClip, a mitral valve transcatheter edge-to-edge repair system, and TriClip, a tricuspid valve transcatheter edge-to-edge repair system. The portfolio also contains transcatheter aortic heart valves — Portico and Navitor. Hence, we expect the market sentiment toward ABT stock to remain positive surrounding the latest development. Abbott holds a market capitalization of $231.29 billion. The company's earnings yield of 3.9% surpasses the industry's 0.6%. ABT delivered an average earnings beat of 1.6% in the trailing four quarters. MAC stiffens the structure of the mitral valve and can lead to mitral regurgitation or stenosis that disrupts the heart's ability to pump blood effectively. The complex nature of this mitral valve disease and patients' specific needs and health conditions can pose challenges for surgical correction. The Tendyne system offers an alternative, minimally invasive way to replace the valve of patients with severe MAC who are at high risk for open-heart surgery. The innovative and unique design of the Tendyne system and the valve's availability in multiple sizes allow it to adapt to a range of patient anatomies. The self-expanding valve is delivered through a small incision in the chest and then advanced into the heart to replace the mitral valve. The valve is fully repositionable and retrievable during implantation, allowing for the best possible outcome for people requiring a valve replacement. Image Source: Zacks Investment Research Per Medi-Tech Insights' report, the TMVR market is projected to witness a compound annual growth rate of 20% from 2025 to 2030. Key factors driving growth are increased prevalence of mitral valve diseases, growing preferences for minimally invasive procedures and expanding geriatric population. Earlier this month, Abbott unveiled results from its REFLECT real-world studies, conducted using data from the comprehensive Swedish National Diabetes Register. The findings revealed that the company's FreeStyle Libre continuous glucose monitoring (CGM) technology helps significantly reduce the risk of hospitalization for heart complications in people with diabetes. Over the past year, Abbott's shares have risen 32%, surpassing the industry's 10.3% growth. Abbott currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader medical space are Phibro Animal Health PAHC, AngioDynamics ANGO and STERIS STE. PAHC carries a Zacks Rank #1 (Strong Buy) at present. It has an estimated long-term earnings growth rate of 26.2% compared with the industry's 15.9%. You can see the complete list of today's Zacks #1 Rank stocks here. Its earnings surpassed the Zacks Consensus Estimate in each of the trailing four quarters, the average surprise being 30.6%. Its shares have rallied 26.3% compared with the industry's 10% growth in the past year. AngioDynamics, carrying a Zacks Rank #1 at present, has an estimated earnings growth rate of 23.7% for 2025. ANGO's earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 70.85%. ANGO's shares have risen 49.2% in the past year compared with the industry's 5.5% growth. STERIS, carrying a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 10.8% for 2025. STE's earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 0.61%. Its shares have risen 34.1% compared with the industry's 7.7% growth in the past year. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Abbott Laboratories (ABT) : Free Stock Analysis Report AngioDynamics, Inc. (ANGO) : Free Stock Analysis Report STERIS plc (STE) : Free Stock Analysis Report Phibro Animal Health Corporation (PAHC) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Yahoo
28-05-2025
- Business
- Yahoo
FDA approves Abbott's TMVR system to treat mitral valve disease
The US Food and Drug Administration (FDA) has granted approval for Abbott's Tendyne transcatheter mitral valve replacement (TMVR) system for individuals with mitral valve disease. This device claims to be the first of its kind to replace the mitral valve without the need for open-heart surgery. It is now available for those whose mitral valves are not working properly due to severe mitral annular calcification (MAC), a condition characterised by calcium buildup within the annulus supporting this valve. Abbott noted that for severe MAC patients at elevated risk for open-heart surgery, as well as those whose mitral valves could not be repaired with the company's MitraClip device, the TMVR system provides a minimally invasive replacement option for the leaky or narrowed valve. Tendyne is indicated for treating symptomatic severe mitral valve dysfunction in patients unsuitable for traditional surgical or transcatheter edge-to-edge repair. Designed to accommodate various patient anatomies, Tendyne is available in several sizes and features a self-expanding valve that can be delivered via a small chest incision and progressed into the heart for mitral valve replacement. The valve is retrievable and repositionable during implantation, optimising patient outcomes. According to Abbott, the health circumstances and requirements of patients, along with the intricate nature of mitral valve disease, present a challenge for surgical intervention. Abbott's structural heart business senior vice-president Sandra Lesenfants said: "Tendyne is a much-needed addition to our comprehensive US structural heart portfolio that offers less invasive treatment options for a range of heart diseases. "This approval builds on our more than two decades of mitral valve leadership, which includes developing first-of-their-kind devices that truly change – and save – people's lives." Abbott's recent REFLECT studies on its FreeStyle Libre continuous glucose monitoring (CGM) technology have cut the risk of hospitalisation for heart complications in individuals with diabetes. "FDA approves Abbott's TMVR system to treat mitral valve disease" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
Yahoo
28-05-2025
- Business
- Yahoo
FDA approves Abbott's TMVR system to treat mitral valve disease
The US Food and Drug Administration (FDA) has granted approval for Abbott's Tendyne transcatheter mitral valve replacement (TMVR) system for individuals with mitral valve disease. This device claims to be the first of its kind to replace the mitral valve without the need for open-heart surgery. It is now available for those whose mitral valves are not working properly due to severe mitral annular calcification (MAC), a condition characterised by calcium buildup within the annulus supporting this valve. Abbott noted that for severe MAC patients at elevated risk for open-heart surgery, as well as those whose mitral valves could not be repaired with the company's MitraClip device, the TMVR system provides a minimally invasive replacement option for the leaky or narrowed valve. Tendyne is indicated for treating symptomatic severe mitral valve dysfunction in patients unsuitable for traditional surgical or transcatheter edge-to-edge repair. Designed to accommodate various patient anatomies, Tendyne is available in several sizes and features a self-expanding valve that can be delivered via a small chest incision and progressed into the heart for mitral valve replacement. The valve is retrievable and repositionable during implantation, optimising patient outcomes. According to Abbott, the health circumstances and requirements of patients, along with the intricate nature of mitral valve disease, present a challenge for surgical intervention. Abbott's structural heart business senior vice-president Sandra Lesenfants said: "Tendyne is a much-needed addition to our comprehensive US structural heart portfolio that offers less invasive treatment options for a range of heart diseases. "This approval builds on our more than two decades of mitral valve leadership, which includes developing first-of-their-kind devices that truly change – and save – people's lives." Abbott's recent REFLECT studies on its FreeStyle Libre continuous glucose monitoring (CGM) technology have cut the risk of hospitalisation for heart complications in individuals with diabetes. "FDA approves Abbott's TMVR system to treat mitral valve disease" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
