Medtronic device cleared by FDA
The U.S. Food and Drug Administration has cleared a minimally invasive pacemaker-implant system from Medtronic that attaches to the inside of the heart in a way that some physicians believe is more healthy for patients in the long term. The new device enables a therapy called “HIS bundle pacing,” which is intended to prevent some patients from developing “pacemaker-induced cardiomyopathy.” Some patients who get traditional “apical” pacing in the right ventricle may eventually develop this form of pacemaker-caused heart failure, past studies have found.
On Wednesday, Medtronic announced FDA clearance for its SelectSite C304-HIS catheter system. The catheter is used to implant the already-cleared Model 3830 pacemaker lead near a natural nerve structure in the heart called the HIS bundle
To produce a healthy heart beat, the heart relies on precisely timed electrical pulses in the left and right ventricles. Normally, pacemaker leads deliver current near the bottom (or “apex”) of the right ventricle, forcing the electricity to pass through heart tissue before it can stimulate the left side. This creates a delay that can elongate the heartbeat and force the left ventricle to work extra hard to compensate, leading to a weakening of the ventricle over time.
HIS bundle pacing delivers electricity higher in the heart, so that the electric pulses from an implanted device can travel along the natural conduction pathways in the heart, triggering more natural timing in the left ventricle. Successful HIS-bundle pacing can theoretically be used to avoid a more complicated implant device called a CRT-P, or cardiac resynchronization therapy pacemaker.
There are drawbacks. It’s more difficult for electrophysiologists to implant the pacemaker lead over the HIS bundle, requiring the doctor to steer a wire inside the heart in a new way. Pacing at the HIS bundle may also require more energy than traditional pacing, and more time in the operating room.
“Pacing at the bundle of [HIS] is a promising procedure with a growing body of clinical evidence,” said Dr. Pugazhendhi Vijayaraman, electrophysiology director at Geisinger Heart Institute in Pennsylvania, and a paid speaker for Medtronic.
Winter takes bite out of Shakopee hospital
St. Francis Medical Center in Shakopee said first-quarter revenue was off due in part to patients staying away from health care during the harsh winter weather.
Minnesota endured it’s coldest air temperatures in more than 20 years in late January followed by the fourth-snowiest February on record.
“For the three months ended March 31, 2019, St. Francis had total operating revenue of [$42.1 million], a slight decrease of 0.8% ... compared to the same time period in 2018,” the hospital said in a financial statement released last week. “Factors impacting operating revenue include declines in patient volumes related to severe winter weather.”
The Star Tribune reported in May that large hospital and clinic operators in the Twin Cities including Allina Health System, Children’s Minnesota and Fairview Health Services all cited the weather plus a mild flu season in reporting diminished financial results for the first quarter.
Located in the southern suburbs of the metro, St. Francis Medical Center is jointly owned by Allina and Bloomington-based HealthPartners. In an interview with the Star Tribune earlier this month, the chief financial officer at HealthPartners, Todd Hofheins, said his organization noticed a weather hit in financial results, as well.
HealthPartners is both a large health insurer and an operator of seven hospitals and roughly 100 medical and dental clinics
Agosto raises expansion capital
Minneapolis-based Agosto Holdings, a cloud-services and development company, has secured $6.5 million in capital from California-based Bridge Bank and SG Credit Partners.
Founded in 2001, Agosto helps clients leverage Google Cloud products for private and public partners, providing technical solutions, training and support, migration from legacy systems and custom-product development.
Agosto, which declined to specify its growth, said it has tripled revenue and head count since 2016. The capital will allow Agosto to advance its strategy within the Google system, add personnel to sales and marketing, and promote Skykit — the first digital signage content-management system built on the Google Cloud Platform.
“Agosto’s relationships with Bridge Bank and SG Credit come after four years of tremendous growth,” said Michael Majerus, Agosto vice president of finance. “Our plans call for an acceleration of this growth in the coming years, and this new capital will allow us to continue to invest in specific areas of the company while maintaining shareholders’ equity interests for the foreseeable future.”
Agosto said it is one of the largest Google-cloud partners globally.
Neal St. Anthony