Boston Scientific Corp. reported the U.S. launch of its Directsense technology, a tool to aid electrophysiologists in measuring tissue response to radiofrequency (RF) waves during cardiac ablation procedures. Approved by the FDA in April, the technology is available on the company’s Rhythmia HDx mapping system.

“We began a controlled launch of the Directsense technology in the U.S. last week and look forward to a full launch in the coming weeks,” Kenneth Stein, senior vice president and chief medical, Rhythm Management and Global Health Policy at Boston Scientific, told BioWorld.

European experience

Directsense was CE marked and launched in Europe two years ago and has seen strong adoption and incorporation into workflows in that market. “It is used with the Rhythmia HDx mapping system, which means the data can be quickly integrated into a 3D map,” Stein said. “It helps physicians know their proximity to, and characteristics of, the tissue, and gives them a sense of viable tissue or scar.”

In patients with paroxysmal atrial fibrillation from the European LOCALIZE clinical trial, local impedance declines of ≥ 16.6 ohms with an inter-lesion spacing of ≤ 6 mm showed a ≥ 98% positive predictive value of durable pulmonary vein block at three months. The results were presented at the Heart Rhythm Society 2020 scientific sessions, which took place virtually in early May due to the COVID-19 pandemic.

“Building upon the success seen with the Directsense technology in Europe, we are pleased to introduce this tool to physicians and their patients in the U.S.,” Stein said. “This approval marks an exciting milestone for our growing electrophysiology portfolio, providing physicians a more direct understanding of lesions and procedural efficiency to obtain optimal patient outcomes.”

Novel approach

The tool works by leveraging electrical fields around the tip of Boston Scientifics’ Intellanav MiFi Open-Irrigated ablation catheter and uses software within the Rhythmia HDx system to provide measures of local impedance around the catheter tip. This is different than generator impedance, which provides data on impedance “from the catheter tip through all the tissue between the catheter and the RF return patch,” Stein explained. By tracking changes in local impedance, Directsense helps physicians understand the characteristics of the tissue they wish to treat and how they are affecting it.

“Knowing the change in impedance around the tip of the catheter provides unique information about local tissue characteristics and the development of the lesion,” said David Callans, professor of medicine ant the University of Pennsylvania’s Perelman School of Medicine, the first U.S. center to use the technology. “Unlike existing products on the market, the Directsense technology assists physicians in evaluating pre-ablation tissue health, while supporting better clinical understanding of how they are influencing that tissue to guide minima, predictable ablation during a procedure.”

Booming market

Currently, the cardiac ablation catheter market is booming. According to Global Market Insights, the worldwide ablation devices market is expected to exceed $6.5 billion by 2026, fueled by an aging population, mounting incidence of atrial fibrillation and growing awareness of advanced treatment options for cardiovascular diseases. Among the main players in the cardiac ablation space, in addition to Boston Scientific, are Abbott Laboratories (St. Jude Medical), Medtronic plc and Stereotaxis Inc.

Smaller companies also are vying in the cardiac ablation space. Last month, Thermedical Inc. won an FDA breakthrough device designation for its saline-enhanced RF ablation system and Durablate catheter in the treatment of ventricular tachycardia. The combination of RF and hot saline acts synergistically to produce consistent treatment volumes that are the precise size the physician needs.

Boston Scientific is looking to boost its overall share in the market. During a May 27 meeting with Sanford C. Bernstein analysts, Boston Scientific CEO Michael Mahoney hinted at a “more disruptive” electrophysiology business in the future, including in cardiac ablation. “In the second half of this year in Europe, you’ll see really a very full portfolio,” he said, pointing to the upcoming launch of Polarx, a recently CE-marked cryoablation system. “We’ll be the only company in the world of EP in Europe who will be able to offer a physician a single-shot cryoballoon that we think is differentiated from the existing incumbent, as well as a full-service mapping platform and a force-sensing catheter, combined with our Directsense catheter. And that portfolio is actually wider than the current market leaders.”

The company plans to start enrolling European patients in a post-approval registry for the device in the coming months.

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