Germany's Biotronik hasn't suffered the same cross-cutting declines as many of its competitors in the heart world, but the company is still staring down a drop in demand for its core cardiac rhythm management business.
But instead of sitting back while the CRM market contracts, Biotronik has spent the past year and change on device R&D, developing ICDs and pacemakers tailored for larger indications and unmet needs.
In May, Biotronik scored FDA approval for its line of next-generation ICD and CRT-D, designed to collect patient data and help doctors track cardiac events. Earlier this month, the company won the agency's blessing to start marketing its Lumax 740 DX, a first-in-class single-lead ICD designed to treat atrial fibrillation. The company expects that device to woo physicians and payers in a market dominated by two-lead technologies, which are more likely to lead to complications. Biotronik is also jumping on the MRI-safe-pacer bandwagon, kicking off a 245-patient trial in the U.S. this year to support a future PMA application.
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Biotronik wins FDA approval for next-gen ICD and CRT-D
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