Respicardia®, a developer of implantable therapies to improve respiratory and cardiovascular health, announced the successful implant of the first commercially-available remede system for patients with Central Sleep Apnea (CSA).
Dr. Bert Hansky performed the first implant at Klinikum Bielefeld in Bielefeld, Germany. Prof. Dr. Christoph Stellbrink is the site's principal investigator.
"I am very happy with my experience with the remede System," said Dr. Hansky. "The implant procedure went as expected and I am confident in the system's ability to reduce the devastating impact of CSA on this patient."
After verification of lead stability, the system was activated for phrenic nerve stimulation to reduce central sleep apnea episodes. "We saw a dramatic reduction in the severity of sleep apnea such that only mild CSA remained after therapy activation," said Prof. Stellbrink. "The patient tolerated the therapy well. This clearly marks an important development in how I will approach treating patients with CSA and cardiovascular disease."
"The company is very excited to complete our first implant outside a formal clinical study," says Bonnie Labosky, president and CEO of Respicardia. "This brings us closer to better understanding the efforts required to help develop this therapy in the marketplace."
Later this month, the company will present findings of its Pilot Study evaluating the effects of the remede® System through 3 months in a poster session at the 2013 European Society of Cardiology (ESC) in Amsterdam.
The remede System is currently being studied in the United States and other international sites under an Investigational Device Exemption (IDE) evaluating the technology's ability to improve respiratory and cardiovascular health in patients with CSA.
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