The outlook for ablation and cardiac rhythm management technologies is looking up, according to Leerink Partners analyst Danielle Antalffy, writing after reviewing the latest offerings from medical device companies at the annual Heart Rhythm Society meeting in Boston recently.
"Our extensive checks with both companies and physicians lead us to believe that current market growth rates – basically flat to up slightly on an organic basis for CRM and strong double-digits for AF ablation – are sustainable for the foreseeable future in large part driven by ongoing innovation among all major players," Antalffy wrote in a note to investors.
Boston Scientific (NYSE:BSX), with its Watchman left atrial appendage closure device, and St. Jude Medical (NYSE:STJ), with its revamped atrial fibrillation ablation business, had the strongest showing at the conference, she noted.
Watchman is poised for dramatic adoption as it becomes commercially available, Antalffy wrote, citing physicians at the conference who suggested "a fairly dramatic adoption ramp" for the anti-stroke cardiac implant.
As for St, Jude, with the TactiCath force-sensing ablation catheter it acquired along with Endosense 2 years ago, "it’s clear that STJ has dramatically strengthened its competitive positioning in AF ablations with TactiCath – an area where STJ has significant opportunity to ramp share from current low double digits to well over 20% in the next few years, more in line with the company’s current mapping market share," she wrote.
Also at the conference, quadripolar cardiac resynchronization therapy devices were the focus of major presentations from both St. Jude and Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ).
Medtronic announced study results detailing the clinical benefits of steroid elution with its Performa quadripolar CRT device. The study showed that steroid-eluting electrodes led to a significant reduction in pacing capture thresholds, suggesting that steroid elution may aid basal pacing (near the top of the heart), avoid phrenic nerve stimulation and prolong generator activity.
"While we have known that steroid-eluting electrodes on cardiac leads are important for chronic cardiac lead performance, this is the first study to demonstrate the benefits of steroid elution on all quadripolar electrodes of a left ventricular lead. The Performa left ventricular lead is unique in having four steroid eluting electrodes, which enables more choices when programming the device, may improve CRT delivery, may reduce complications of left ventricular pacing, and will give peace of mind over the chronic performance of the Performa lead," Northwestern University’s Dr. Albert Lin said in a press release.
Another Attain Performa analysis looked at the importance of pacing vector assessments, finding that over 12 months, 40% of patients optimal pacing vectors changed. Medtronic said that shows the importance of assessing and optimizing the vectors on a regular basis.
A St. Jude study showed its quadripolar CRT-P is associated with a significant reduction in left ventricle lead deactivation and replacement, the company said. An analysis of over 3,000 patients found that those with St. Jude’s quadripolar CRT-P were 63% less likely to need lead replacement or deactivation, compared to patients with bipolar leads.
"There is a strong body of evidence indicating that quadripolar resynchronization leads are associated with fewer complications and better outcomes when used with implantable defibrillators. However, we didn’t know whether these benefits extended to pacemakers. The current study showed that even in cardiac resynchronization pacemakers, the quadripolar lead was associated with fewer complications in the first three months," Stanford’s Dr. Mintu Turakhi said in a prepared statement.
Another study of STJ’s quad CRT device also showed improved clinical outcomes, increased survival and better cost utilization with the device. An analysis of 8,973 patients with high and low percentages of biventricular pacing showed a 24% lower mortality rate for patients with a high percentage of biventricular pacing when using St. Jude’s system with a quadripolar lead, the company said.
St. Jude also reported on a separate study of its Quartet LV quadripolar leads that showed a 31% reduction in post-implant heart failure hospitalization rates and a 39.8% reduction in associated costs compared to CRT-D patients with bipolar LV leads.
Here’s a look at a few more studies highlighted at the conference:
St. Jude’s CardioMEMS HF: 43% reduction in hospitalization in CRT/ICD high-risk patients
St. Jude Medical (NYSE:STJ) says a new study shows reduced hospitalization and an improved survival rate for CRM device patients when the company’s CardioMEMS HF PA Pressure monitor.
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Shorter hospital stays, lower cost with Masimo’s PVI
Masimo (NSDQ:MASI) says a new study shows a 2.3 day shorter average hospital stay, 7.3% infection rate and significantly reduced direct costs when the company’s PVI is used in perioperative recovery program.
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Medtronic’s Tyrx antibacterial envelope drops infection rate 80%
Medtronic (NYSE:MDT) says a new study shows an 80% reduction in infections in study of 1,129 patients treated with the company’s Tyrx absorbable antibacterial envelope during electronic device implantations.
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Acutus Medical’s AcQMap generates 4x resolution map
Acutus Medical says its new AcQMap system generates a 3D cardiac map that has 4x the resolution of standard voltage based mapping systems.
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CVRx looks to non-CRT market for Barostim
The Barostim device made by CVRx, which is headed for a U.S. pivotal trial later this year, showed strong results in an early feasibility trial comparing it in patients with or without cardiac resynchronization therapy devices. "There is a significant unmet medical need for patients with advanced, chronic heart failure despite having received guideline-directed therapies, and in particular, for those patients who are not candidates for CRT," president & CEO Nadim Yared said in prepared remarks.
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