Denver—Biotronik featured its Evia pacemaker equipped with patient monitoring and remote follow-up capabilities at the Heart Rhythm Society (HRS) scientific sessions May 12-15.
The company announced on May 12 that it had received FDA clearance for the device for distribution in the U.S.
“The most important thing about Evia is its small size, it’s durability and its ability to provide home monitoring,” Rex Richmond, VP of marketing and communication for Biotronik’s U.S. sector, told Cardiovascular Business News.
According to Richmond, the small size of the pacemaker device is equipped with three parts: the device itself, a transmitter and a web-based application that can link to any computer to transmit patient data to a physician for follow-up.
Richmond said that Evia is different than most monitoring devices because of its ability to be a cellular, mobile-based device that is completely wireless.
“It’s literally like a cell phone that immediately notifies a physician that something has gone wrong with the patient or their device,” he said.
According to Richmond, the device, which is 20 percent smaller than current products, produces better longevity and can last up to 10 years rather than the standard device that lasts only five to seven years before the need for replacement.
Due to its increased longevity, patients will undergo device replacement less frequently, improving the rate of procedural complications such as infection.
Heart patients implanted with the Evia pacemaker have the ability to be remotely monitored through Biotronik’s home monitoring wireless system that calls for one annual in-clinic visit per year.
“The Evia provides better outcomes because it’s smaller and you don’t have to worry about the lifespan of the product,” said Richmond.
While the Berlin-based company is involved in the sectors of electrophysiology and vascular intervention in Europe, Richmond said the company is looking to expand these businesses throughout the U.S.
According to Richmond, the devices for ablation and intravascular procedures are in the protocol development stage in the U.S. and will undergo clinical trials and be submitted to the FDA for approval.
“We are only in the very early stages in the U.S. but we plan to move very quickly when we come into the U.S. market because our technologies are already developed in Europe,” said Richmond.
The company will first launch its drug-eluting absorbable metal stent (DREAMS) product line to be used during vascular interventions, he said.