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Medtronic's (MDT) Newest Evolut TAVR System Gets FDA Approval
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Medtronic plc (MDT - Free Report) recently secured the FDA’s approval for the Evolut FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The latest Evolut FX+ TAVR system maintains the valve performance benefits of the legacy Evolut TAVR platform and is designed to facilitate coronary access.
The latest development will significantly boost the Coronary & Renal Denervation and Structural Heart & Aortic businesses, which are part of Medtronic’s Cardiovascular portfolio. Early Commercial Experience is planned for spring 2024, with a full product launch expected in summer 2024.
News in Detail
Severe aortic stenosis occurs when aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body. The condition often reduces a patient's quality of life and limits their daily activities. If left untreated, 50% of patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years.
Image Source: Zacks Investment Research
Medtronic’s commitment to consistently developing and advancing minimally invasive solutions for physicians treating aortic stenosis is evident from its continued innovation of the Evolut TAVR platform, which has delivered proven valve performance and durability to physicians and patients for years.The Evolut FX+ TAVR system was designed to facilitate coronary access across a diverse range of patient anatomies with no compromise to valve performance.
The new system offers larger coronary access windows through a modified diamond-shaped frame design, which is four times larger than the previous iterations of the Evolut TAVR system. Evolut FX+ provides increased space for catheter maneuverability to facilitate access to coronary arteries of varying patient anatomies. In addition, the new design does not compromise the market-leading valve performance, superior hemodynamics and radial strength that clinicians expect from the Evolut platform.
In the United States, the Evolut FX+ TAVR system is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low).
Industry Prospects
Per a Research report, the global aortic stenosis market was valued at $8.33 billion in 2023 and is expected to witness a CAGR of 10.5% by 2030.
Other Developments in the Cardiovascular Portfolio
In January 2024, Medtronic received the CE Mark for the next generation of its industry-leading miniature, leadless pacemakers, Micra AV2 and Micra VR2. In addition to size and longevity benefits, Micra devices are also the only leadless pacemakers with remote monitoring capabilities, which allow a doctor or clinic to check on a patient's heart device without the need for a patient to travel to their clinic for an in-person appointment. Both Micra AV2 and VR2 devices received FDA approval in 2023.
Earlier in December 2023, the company also secured FDA approval for the PulseSelect Pulsed Field Ablation (“PFA”) System for the treatment of both paroxysmal and persistent atrial fibrillation. By combining the PulseSelect PFA system with the CE Marked Affera mapping and ablation system and the Cryo platform, Medtronic is able to provide a broad portfolio of solutions to clinicians and their patients, developed with years of research and supported by compelling scientific evidence.
Price Performance
In the past six months, Medtronic shares have risen 12.1% compared with the industry’s growth of 15.2%.
Zacks Rank and Key Picks
Medtronic currently carries a Zacks Rank #3 (Hold).
Cardinal Health’s stock has surged 45.8% in the past year. Earnings estimates for Cardinal Health have risen from $7.28 to $7.29 in fiscal 2024 and from $8.03 to $8.04 in fiscal 2025 in the past 30 days.
CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 15.6%. In the last reported quarter, it posted an earnings surprise of 16.7%.
Estimates for Stryker’s 2024 earnings per share have remained constant at $11.86 in the past 30 days. Shares of the company have moved 24.4% upward in the past year compared with the industry’s rise of 5.8%.
SYK’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 5.1%. In the last reported quarter, it delivered an average earnings surprise of 5.8%.
Estimates for DaVita’s 2024 earnings per share have moved up from $8.97 to $9.23 in the past 30 days. Shares of the company have surged 69% in the past year compared with the industry’s 23.4% rise.
DVA’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 35.6%. In the last reported quarter, it delivered an average earnings surprise of 22.2%.
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Medtronic's (MDT) Newest Evolut TAVR System Gets FDA Approval
Medtronic plc (MDT - Free Report) recently secured the FDA’s approval for the Evolut FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The latest Evolut FX+ TAVR system maintains the valve performance benefits of the legacy Evolut TAVR platform and is designed to facilitate coronary access.
The latest development will significantly boost the Coronary & Renal Denervation and Structural Heart & Aortic businesses, which are part of Medtronic’s Cardiovascular portfolio. Early Commercial Experience is planned for spring 2024, with a full product launch expected in summer 2024.
News in Detail
Severe aortic stenosis occurs when aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body. The condition often reduces a patient's quality of life and limits their daily activities. If left untreated, 50% of patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years.
Image Source: Zacks Investment Research
Medtronic’s commitment to consistently developing and advancing minimally invasive solutions for physicians treating aortic stenosis is evident from its continued innovation of the Evolut TAVR platform, which has delivered proven valve performance and durability to physicians and patients for years.The Evolut FX+ TAVR system was designed to facilitate coronary access across a diverse range of patient anatomies with no compromise to valve performance.
The new system offers larger coronary access windows through a modified diamond-shaped frame design, which is four times larger than the previous iterations of the Evolut TAVR system. Evolut FX+ provides increased space for catheter maneuverability to facilitate access to coronary arteries of varying patient anatomies. In addition, the new design does not compromise the market-leading valve performance, superior hemodynamics and radial strength that clinicians expect from the Evolut platform.
In the United States, the Evolut FX+ TAVR system is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low).
Industry Prospects
Per a Research report, the global aortic stenosis market was valued at $8.33 billion in 2023 and is expected to witness a CAGR of 10.5% by 2030.
Other Developments in the Cardiovascular Portfolio
In January 2024, Medtronic received the CE Mark for the next generation of its industry-leading miniature, leadless pacemakers, Micra AV2 and Micra VR2. In addition to size and longevity benefits, Micra devices are also the only leadless pacemakers with remote monitoring capabilities, which allow a doctor or clinic to check on a patient's heart device without the need for a patient to travel to their clinic for an in-person appointment. Both Micra AV2 and VR2 devices received FDA approval in 2023.
Earlier in December 2023, the company also secured FDA approval for the PulseSelect Pulsed Field Ablation (“PFA”) System for the treatment of both paroxysmal and persistent atrial fibrillation. By combining the PulseSelect PFA system with the CE Marked Affera mapping and ablation system and the Cryo platform, Medtronic is able to provide a broad portfolio of solutions to clinicians and their patients, developed with years of research and supported by compelling scientific evidence.
Price Performance
In the past six months, Medtronic shares have risen 12.1% compared with the industry’s growth of 15.2%.
Zacks Rank and Key Picks
Medtronic currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Cardinal Health (CAH - Free Report) , Stryker (SYK - Free Report) and DaVita (DVA - Free Report) . While Cardinal Health and Stryker each carry a Zacks Rank #2 (Buy), DaVita sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Cardinal Health’s stock has surged 45.8% in the past year. Earnings estimates for Cardinal Health have risen from $7.28 to $7.29 in fiscal 2024 and from $8.03 to $8.04 in fiscal 2025 in the past 30 days.
CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 15.6%. In the last reported quarter, it posted an earnings surprise of 16.7%.
Estimates for Stryker’s 2024 earnings per share have remained constant at $11.86 in the past 30 days. Shares of the company have moved 24.4% upward in the past year compared with the industry’s rise of 5.8%.
SYK’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 5.1%. In the last reported quarter, it delivered an average earnings surprise of 5.8%.
Estimates for DaVita’s 2024 earnings per share have moved up from $8.97 to $9.23 in the past 30 days. Shares of the company have surged 69% in the past year compared with the industry’s 23.4% rise.
DVA’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 35.6%. In the last reported quarter, it delivered an average earnings surprise of 22.2%.