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Can UltiSynq Lead Boost Abbott's Cardiac Rhythm Management Business?
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Key Takeaways
ABT secured FDA and CE Mark approvals for UltiSynq, a lead offering both pacing and defibrillation therapy.
Abbott's ASCEND CSP IDE trial showed a 98.5% successful implantation rate across 205 attempts.
ABT's UltiSynq posted a 97.5% complication-free rate, with successful defibrillation in 120 tested patients.
Abbott (ABT - Free Report) is adding to its comprehensive cardiac rhythm management portfolio with the FDA approval and CE Mark approvals of the UltiSynq defibrillation lead. The device is designed to deliver both conduction system pacing and defibrillation therapy, providing an additional lead option for patients who are candidates for both treatments.
Nearly 150,000 ICDs are implanted in the United States and 140,000 in Europe annually, highlighting the importance of pacing performance for a large patient population. Left bundle branch area pacing (LBBAP) has emerged as a conduction system pacing approach aiming to restore the heart's natural pattern of electrical activation.
The FDA approval and CE Mark for UltiSynq were supported by results from the ASCEND CSP IDE trial, a global, multicenter study evaluating the lead's safety and effectiveness in patients requiring ICD or cardiac resynchronization therapy defibrillator (CRT-D) therapy.
Three-month results, presented at the Heart Rhythm Society annual meeting in April 2026, showed that UltiSynq exceeded all prespecified primary safety and effectiveness endpoints. The trial showed a 98.5% successful implantation rate across 205 attempts. Physicians needed less than one repositioning attempt per patient on average to identify the pacing target. Among patients with successful implants, 86% achieved LBBP or likely LBBP, while the remaining 14% had left ventricular septal pacing. The major complication-free rate stood at 97.5% at three months, above the prespecified safety goal. Defibrillation was also successful in all 120 patients who completed testing, without requiring lead repositioning.
Abbott’s UltiSynq has also received the FDA's breakthrough device designation, which speeds up the development and review of devices aimed at improving the treatment or diagnosis of life-threatening or serious conditions.
Updates From ABT Peers
Medtronic (MDT - Free Report) recently announced primary endpoint results from the SPYRAL AFFIRM post-approval study of its Symplicity Spyral renal denervation (RDN) system. The study showed statistically significant and clinically meaningful blood pressure reductions at six months, including office, home and 24-hour ambulatory blood pressure, with no increase in antihypertensive medications. Medtronic also received FDA approval to update the labeling for its Symplicity Spyral Multi-Electrode Renal Denervation Catheter. The update was backed by clinical evidence from the SPYRAL HTN program, including the SPYRAL AFFIRM study and the Global SYMPLICITY Registry DEFINE.
Boston Scientific (BSX - Free Report) announced positive six-month primary endpoint results from the SIMPLAAFY randomized controlled trial of the WATCHMAN FLX Pro Left Atrial Appendage Closure Device. The study evaluated two single-drug regimens as alternatives to dual antiplatelet therapy following device implantation in patients with non-valvular atrial fibrillation. Meanwhile, Boston Scientific’s Cardiac Rhythm Management sales declined 2% in the third quarter of 2026, partly reflecting the impact of the cyber incident, which disrupted the use and activation of remote monitoring technologies while the systems were unavailable.
ABT’s Price Performance, Valuation & Estimates
Over the past year, ABT shares have plunged 12.2% compared with the industry’s 18.1% decline.
Image Source: Zacks Investment Research
In terms of valuation, Abbott is trading at a forward, five-year Price/Sales (P/S) of 3.60X, lower than its 4.56X median but above its industry average of 2.35X.
Image Source: Zacks Investment Research
Here’s how consensus estimates for Abbott's 2026 and 2027 earnings have been shaping up.
View the Zacks #1 Rank List
Image: Bigstock
Can UltiSynq Lead Boost Abbott's Cardiac Rhythm Management Business?
Key Takeaways
Abbott (ABT - Free Report) is adding to its comprehensive cardiac rhythm management portfolio with the FDA approval and CE Mark approvals of the UltiSynq defibrillation lead. The device is designed to deliver both conduction system pacing and defibrillation therapy, providing an additional lead option for patients who are candidates for both treatments.
Nearly 150,000 ICDs are implanted in the United States and 140,000 in Europe annually, highlighting the importance of pacing performance for a large patient population. Left bundle branch area pacing (LBBAP) has emerged as a conduction system pacing approach aiming to restore the heart's natural pattern of electrical activation.
The FDA approval and CE Mark for UltiSynq were supported by results from the ASCEND CSP IDE trial, a global, multicenter study evaluating the lead's safety and effectiveness in patients requiring ICD or cardiac resynchronization therapy defibrillator (CRT-D) therapy.
Three-month results, presented at the Heart Rhythm Society annual meeting in April 2026, showed that UltiSynq exceeded all prespecified primary safety and effectiveness endpoints. The trial showed a 98.5% successful implantation rate across 205 attempts. Physicians needed less than one repositioning attempt per patient on average to identify the pacing target. Among patients with successful implants, 86% achieved LBBP or likely LBBP, while the remaining 14% had left ventricular septal pacing. The major complication-free rate stood at 97.5% at three months, above the prespecified safety goal. Defibrillation was also successful in all 120 patients who completed testing, without requiring lead repositioning.
Abbott’s UltiSynq has also received the FDA's breakthrough device designation, which speeds up the development and review of devices aimed at improving the treatment or diagnosis of life-threatening or serious conditions.
Updates From ABT Peers
Medtronic (MDT - Free Report) recently announced primary endpoint results from the SPYRAL AFFIRM post-approval study of its Symplicity Spyral renal denervation (RDN) system. The study showed statistically significant and clinically meaningful blood pressure reductions at six months, including office, home and 24-hour ambulatory blood pressure, with no increase in antihypertensive medications. Medtronic also received FDA approval to update the labeling for its Symplicity Spyral Multi-Electrode Renal Denervation Catheter. The update was backed by clinical evidence from the SPYRAL HTN program, including the SPYRAL AFFIRM study and the Global SYMPLICITY Registry DEFINE.
Boston Scientific (BSX - Free Report) announced positive six-month primary endpoint results from the SIMPLAAFY randomized controlled trial of the WATCHMAN FLX Pro Left Atrial Appendage Closure Device. The study evaluated two single-drug regimens as alternatives to dual antiplatelet therapy following device implantation in patients with non-valvular atrial fibrillation. Meanwhile, Boston Scientific’s Cardiac Rhythm Management sales declined 2% in the third quarter of 2026, partly reflecting the impact of the cyber incident, which disrupted the use and activation of remote monitoring technologies while the systems were unavailable.
ABT’s Price Performance, Valuation & Estimates
Over the past year, ABT shares have plunged 12.2% compared with the industry’s 18.1% decline.
Image Source: Zacks Investment Research
In terms of valuation, Abbott is trading at a forward, five-year Price/Sales (P/S) of 3.60X, lower than its 4.56X median but above its industry average of 2.35X.
Image Source: Zacks Investment Research
Here’s how consensus estimates for Abbott's 2026 and 2027 earnings have been shaping up.
Image Source: Zacks Investment Research
Abbott currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.