A race to the future is taking place right now in the Twin Cities, as rival companies battle it out to build the next generation of equipment for millions of heart patients.
The goal? To create a wireless pacemaker so small that it is inserted inside the heart itself.
The competitors? Minneapolis-based Medtronic is racing against St. Paul-based St. Jude Medical to be the first to perfect a model, but lurking in the background is Massachusetts-based Boston Scientific, which has its cardiac rhythm division in, you guessed it, the Twin Cities.
This week Bloomberg profiled the competition between Medtronic and St. Jude, which have both been developing an advanced version of traditional pacemakers that would see a tiny wireless device inserted into the right ventricle of the heart using a catheter.
The device could be used for patients who need heart pacing in only one chamber, which according to Bloomberg accounts for roughly 30 percent of the 1 million pacemakers sold each year, meaning the market could be worth a potential $700 million.
That amount could grow as the ease of inserting the device – compared to the current wired versions, which must be implanted by surgeons – opens it up to emerging markets such as India.
They are unlike the existing pacemakers that are used to regulate the heart rhythms of patients with arrhythmias. Those are placed under the skin near the shoulder and are connected to the heart using wires, according to MedicineNet.
"The wires can cause blood clots in the veins, scar tissue formation or infections," John Day, president of the Heart Rhythm Society, told Bloomberg, adding that with mini-pacemakers, "there is nothing visible in the chest. There are no wires to break."
The Star Tribune reported last month that St. Jude began trials of its "Nanostim" product in 2013, when it gained approval to sell it in Europe, following it up with a clinical trial in the U.S. that started in January 2014.
Medtronic followed up earlier this year by getting European approval for an even smaller leadless pacemaker it called the "Micra," and has started a "large-scale trial in the U.S.," while Boston Scientific is developing its own product that doesn't even have a name yet.
But St. Jude has run into problems with its Nanostim product, with the newspaper noting it has twice stopped implants following reports of complications.
According to Qmed, it most recently suspended trials after reports that two people among the 200 people who first received the pacemaker had died, with a few others reporting they had suffered perforations.
An investigation found that the complications were caused by "inappropriate patient selection" and "operator inexperience" rather than any issue with the device itself, Qmed notes.
Medtronic looks to capitalize
According to MDDI, St. Jude is working with European regulators to update its training protocols and hopes to resume trials soon.
But this has opened a door that Medtronic hopes to take advantage of – announcing in April that the first 140 patients it had implanted had experienced "a successful implant procedure."
Both are now pushing ahead to get these products to market, with Bloomberg reporting that St. Jude plans to seek approval to sell Nanostim in the U.S. later this year, with Medtronic to follow next year with Micra.
With prices and revenue in traditional pacemakers falling over the past five years, it is believed that these tiny wireless devices are the future – and whomever emerges as the market winner, it appears certain that the Twin Cities will be at the center of the industry for some time to come.