The FDA approval of St. Jude Medical and CardioMEMS' implantable wireless heart monitoring device has gotten the medtech world excited and that includes a competitor.
St. Jude Medical and CardioMEMS are not the only two entities celebrating the FDA approval of the world’s first implantable wireless pulmonary artery pressure sensing device for heart failure patients on Wednesday.
Upstart competitor, Woodridge, Illinois-based Endotronix is cheering as well.
“There’s been a lot of interest in the wireless pulmonary artery pressure sensing space, and there’s been a lot of regulatory headaches,” said Harry Rowland, co-founder and CEO of Endotronix, in an interview before the FDA approval was announced. “People want to see the CardioMEMS device get through the regulatory process.”
When that happens, he added it will be a “big announcement, not just to CardioMEMS and St. Jude and congratulations to them, but also to unlock the potential in the field.”
|CardioMEMS' Implantable Wireless Sensor|
The CardioMEMS HF System comprises a wireless sensor that is implanted on the pulmonary artery. When a reading at home needs to be taken, the patient lies down on CardioMEMS' large pillow/mattress for a few seconds which is connected via a cable to a transmitter. The transmitted collects the information from the implanted wireless sensor and transmits to physicians.
Rowland explained that attempts to craft such a technology goes back to the 1950s and 1960s, but the technology wasn’t up to snuff and nothing was commercialized. The field became dormant for a while only to have reemergence in the 90s and early 2000s.
Even then there has been hiccups. FDA rejected the CardioMEMS device a few years ago, and this time around has asked for a post-approval study to determine how well the device works outside the clinical-trial setting. But the utility of PA pressure sensing is well known.
“Physicians, nurses have been using PA pressure measurement for 30 years in clinical care. They know exactly what it is. They know what to do with it. But they've only gotten it when the patient is supine in the hospital with the catheter inside their neck or leg coming out,” Rowland said. “They have never had access to this information on a large scale inside a patient’s home. And [CardioMEMS’] Champion trial showed that once a day reading typically in the morning can have a clinical impact.”
But Rowland feels that while the CardioMEMS product is revolutionary, it is lacking in the category of patient experience. The transmitter, the size of a "PC tower," the cables and the pillow together make up “40 pounds worth of capital equipment that the patient has to take home and install,” he says.
|CardioMEMS Pillow With Transmitter|
“The CardioMEMS system works great," he said. "They've done a really great job with it but they really designed a supercomputer for the patient's home to take these readings. The transmitter is a tall, heavy bedside unit. It's an issue that comes up again and again when we talk to patients. It obtrudes their daily life experience.”
In a public FDA meeting to discuss the CardioMEMS device back in December 2011, Rowland says he spoke with patients who were concerned about the large equipment. Others later said the same thing. However, a patient who testified at that meeting said that the equipment was simple, and "a little bit large in size but still very transportable."
Nonetheless, drawing on consumer devices that are mobile, Endotronix is developing a reader technology that will be the main differentiator from the CardioMEMS device. Both products work with a wireless implantable pressure sensor.
“The core platform that we are developing is the iPad mini-type size but the technology is adaptable to where it could be put in a chair pad, or a mattress pad similar to CardioMEMS or can be put in a vest to take a look at the pressures doing exercise and throughout the day,” he said. "So it’s a flexible technology that meets a variety of patient needs.”
Patients will be able to take the system along when they are traveling, which is hard to do with the CardioMEMS system, he said.
A statement from St. Jude Medical showed that company executives were unwilling to comment on "non-St Jude technologies." The statement also said the company has not disclosed any plans on a next-generation CardioMEMS technology.
Currently, Endotronix is testing the system in animals. It hopes to launch a pilot, safety trial later this year. The actual FDA approval is still several years away, Rowland said.
Meanwhile, Endotronix is building a communication platform that will work with smart devices to not only collect and transmit PA pressure data but also, daily blood pressure, weight, pulse oximetry, activity and other data as needed.
"You do need to look at weight and blood pressure and self-reported patient symptoms and you need to make sure that the physicians communicate that information with the patients and act on that information," he said. "So we want to tie in that communication loop and we are building that platform now in parallel with our sensor implant because we need that system in place to maximize the value of the information you get via the implanted sensor."
Endotronix is in talks with pharma companies who want to use the care/communication software platform to boost patient well-being, adherence to drugs and help in disease management, he said.
So far the company has raised $13 million from angels and other entities. Endotronix is currently looking to raise its first institutional round of investment worth $12 million. Rowland expects CardioMEM's FDA approval will help in this regard.
"The FDA approval can open up the doors of investment in this space," he said.
[Featured Photo Credit: iStockphoto.com user hidesy]
UPDATED: Story updated with a statement from St. Jude Medical.