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Boston Scientific commences Ingevity pacing leads trial
Boston Scientific has announced the commencement of a new study that will assess the benefits offered by its next-generation Ingevity pacing leads.
The company is aiming to establish the safety, performance and effectiveness of the leads, which offer advantages in terms of manoeuvrability, reliability, fixation and electrical performance compared to standard leads, as well as being compatible with MRI scanning.
In October 2012, the first patient was implanted with the leads in Stockholm, with clinicians stating that they were impressed with the level of control offered when placing the devices.
It is hoped that data from this new clinical trial will support the company's efforts to gain US and EU regulatory approval for the product, with around 1,000 patients to be enrolled across 16 countries.
Dr Kenneth Stein, senior vice-president and chief medical officer of the cardiac rhythm management business at Boston Scientific, said: "We believe Ingevity reflects all of these design principles, with the goal of improving the quality of patient care across the globe."
Earlier this month, the firm also begun enrolment for a randomised study of the WallFlex Biliary RX fully covered self-expanding metal stent, which is intended for use in the treatment of chronic pancreatitis.
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