Mechanical devices implanted in the body can pump the blood for a failing heart, but they have a critical limitation: They require a permanent driveline that exits the skin to connect to components outside the body.
A line as big as a pinkie finger permanently sticking out of the skin creates infection risk and can serve as an unwanted conversation-starter for patients with advanced heart failure — serious drawbacks even for devices that can extend a person's life.
"Committing a patient to a driveline for life has kept this field from blossoming," said Dr. William Cohn, a renowned surgeon and researcher at the Texas Heart Institute.
Now Eden Prairie's Sunshine Heart is teaming with a St. Paul company to make a heart pump that runs on power transmitted through the skin. The idea has excited some investors, though many hurdles remain, including getting positive clinical results from researchers and marketing approval from regulators.
The idea of powering a medical device with transcutaneous energy, or power sent wirelessly through the skin, is already used in low-energy devices like neurostimulators and hearing implants. But none of the heart-pump makers around the country have figured out how to make it work for their higher-powered machines with moving parts.
Sunshine Heart officials are hopeful. They announced last week that the company will begin human testing of their device, known as the C-Pulse II, sometime next year. Cohn is leading the international study. Like most new medical devices, the first implants are expected to take place in countries outside the U.S.
To eliminate the driveline from its original C-Pulse system, Sunshine Heart is licensing transcutaneous energy transmission technology (TETS) from St. Paul-based Minnetronix, which designs and supplies components for many companies' medical devices.
Sunshine Heart's device fits in a class of complex heart implants called mechanical circulatory support devices, which pump blood when a patient's heart can't, even with a pacemaker. Another company in the field is California-based Thoratec Corp., which St. Jude Medical plans to acquire for $3.4 billion. (Thoratec is a minority owner of Sunshine Heart, the company has disclosed in regulatory filings, which means St. Jude would own part of Sunshine Heart if that deal takes place.)