Medtronic | January 11, 2022
Medtronic plc, a global leader in healthcare technology,today announced it has received approval fromJapan'sMinistry of Health, Labor and Welfare for the sale and reimbursement of the Micra™ AV Transcatheter Pacing System (TPS), and the company will launch the product this month.
This approval expands the number of patients inJapan– one of the largest markets in the world – who are eligible to receive the Micra TPS, the world's smallest pacemaker. The Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired. The Micra TPS is the first-ever leadless pacemaker; its first version (the Micra VR) was approved inJapanin 2017 for patients who only require single-chamber pacing.
"Pacemakers have made significant progress over their approximately 60-year history, including miniaturization, improvements in pacing technology, MRI compatibility, and remote monitoring," explainedKyoko Soejima, professor of cardiovascular internal medicine at Kyorin University Hospital and a member of the Micra TPS Global Clinical Trial steering committee. "The first Micra system transformed the concept of pacemakers by eliminating surgical pockets and leads, and Micra AV promises to deliver the benefits of leadless pacing to a larger number of patients because ventricular pacing can be performed synchronously with the atrium."
Historically, patients with AV block have been treated with traditional dual-chamber pacemakers which are implanted in the upper chest, under the skin below the collar bone, and connected to the heart using thin wires called "leads." Identical in size and shape to the original Micra TPS, Micra AV has several additional algorithms which detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, providing "AV synchronous" pacing therapy to patients with AV block.
The Micra AV approval is based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. The study evaluated the ability of the Micra's internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony.
"Since introducing the first battery-powered external pacemaker in 1957 to the innovative Micra leadless pacemaker portfolio, Medtronic continues to pioneer pacing innovations for physicians and their patients."
Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiac Rhythm Management business at Medtronic
About the Micra Transcatheter Pacing Systems (TPS)
The Micra TPS received CE Mark inApril 2015and U.S. FDA approval in 2016. Comparable in size to a large vitamin, Micra is less than one-tenth the size of traditional pacemakers yet delivers advanced pacing technology to patients via a minimally invasive approach. During the implant procedure, the device is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.
Unlike traditional pacemakers, Micra does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to leads and pockets are reduced, and there is no visible sign of the device.
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered inDublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.
Graham Healthcare Group | December 21, 2021
Graham Healthcare Group, a leader in homecare, palliative and hospice services, today announced its acquisition of InTeliCare Health Services, a provider of home health services in central Florida. The agreement was finalized on December 15th, 2021, and marks Graham's first expansion into Florida.
Graham will integrate InTeliCare into its Residential Home Health division to accelerate access to personalized home health care throughout Florida. Residential is a leading post-acute home care network serving communities in Michigan, Illinois and Pennsylvania.
Integrating InTeliCare into Residential Home Health will bring together industry-leading, patient-centered home health services to strengthen the continuum of care for patients across central Florida.
"More than one-fifth of Florida's population is over 65, and that number continues to grow. With the baby boomer generation doubling in size and an increase in comorbidities, this is an ideal time for Graham Healthcare Group to begin serving people in the state of Florida in their own homes with high-quality post-acute and end-of-life care."
David Curtis, Chief Executive Officer of Home Health at Graham Healthcare Group
"With the addition of InTeliCare, we're poised for growth as we continue our mission to transform home care and improve patient experiences," Curtis said. "This agreement expands the ability of Graham Healthcare Group to deliver consistent, high-quality care across the spectrum of home health and further strengthens our foundation for success."
Irene Tuttle, InTeliCare Founder and Chief Executive Officer, will serve in an advisory role following the deal's close. Toni Walker, InTeliCare's longstanding Vice President of Operations, will maintain leadership over day-to-day operations.
"We strongly align with Residential's values of care and community," Tuttle said. "This is an extraordinary opportunity to join forces with an organization that shares our employee- and patient-driven approach to care."
"We are confident that the powerful synergies and added strength this partnership creates will continue to elevate the value and experience of post-acute care and advance the continuum of home health care in central Florida," Tuttle added.
Residential Home Health intends to retain InTelicare's workforce and will support them with enhanced operational efficiencies and advanced clinical and technology innovations.
Both Residential Home Health and InTeliCare are known for strong, employee-friendly cultures. Residential has been recognized as a top workplace for 11 consecutive years in the Detroit market and was recognized in the Chicago and St. Louis markets in 2021.
About Graham Healthcare Group
A subsidiary of Graham Holdings Company, Graham Healthcare Group has designed business and technology solutions to drive better care, outcomes and productivity in home health and hospice services for more than 20 years. Itincludes Residential Healthcare Group, Allegheny Health Network-Healthcare @ Home, Mary Free Bed at Home, Clarus, and CSI Pharmacy. Itis deeply committed to radically changing the home care model by putting patients and their families at the top of the paradigm, while enhancing the quality and consistency of healthcare in the most convenient and cost-effective setting possible: at home.
About Residential Home Health
Based in Troy, Michigan, Residential Home Health is a leading provider of home health, palliative and hospice services in Michigan, Illinois and Pennsylvania. Residential is one of the fastest growing home health networks with 2,500 dedicated care professionals.
About InTeliCare Health Services
Based in Boca Raton, InTeliCare is a leading provider of home health services in central Florida. The company has 80 employees serving nearly 300 patients from three offices.
L2Mtech | February 17, 2021
CE Mark Approval for LimusTrack™, Sirolimus Eluting Coronary Stent System for Cardiovascular Applications.
CE Mark Approval for LomiFlow™, Paclitaxel Drug Eluting Balloon for Cardiovascular Applications
CE Mark Approval for PearlFlow™, Paclitaxel Drug Elutin Balloon for Endovascular Applications
CE Mark Approval for PearlFlow NS™, Self Expandable Nitinol Stent System for Endovascular Applications
CE Mark Approval for FlexiTrack 018™, Peripheral Balloon Catheter for Endovascular Applications
CE Mark Approval for FlexiTrack 035™, Peripheral Balloon Catheter for Endovascular Applications
Bonn, Germany – L2Mtech GmbH has announced the award of its first CE Mark approval on Six (6) products:
LimusTrack™ : Sirolimus Coated Cobalt Chromium Stent with biodegradable polymer for the treatment of coronary artery disease, de novo lesions, restenosis lesions.
LomiFlow™ : Paclitaxel Coated balloon catheter for the treatment of coronary artery disease, small vessels, dilatation of de novo lesions, in-stent restenosis (ISR) cases.
PearlFlow™ : Paclitaxel Coated balloon catheter for the treatment of peripheral arterial disease, PTA, dilatation of stenotic segments or lesions in peripheral arteries.
PearlFlow NS™ : Self-Expanding Nitinol Stent System for the treatment of peripheral arterial disease, de novo lesions, lesions in femoropopliteal arteries.
FlexiTrack 018™ : Peripheral Balloon Dilatation catheter for the treatment of peripheral arterial disease, dilatation of lesions in femoral, popliteal, tibial arteries.
FlexiTrack 035™ : Peripheral Balloon Dilatation catheter for the treatment of peripheral arterial disease, dilatation of lesions in the SFA, femoral arteries.
L2Mtech GmbH Founder and CEO Lalit Mamtani said ‘‘We are very excited to have been awarded our first CE Mark on six products, CE Mark approval represents a key milestone for L2Mtech GmbH and is a testament to the efficacy and safety of our innovative technology products for Cardiovascular and Endovascular applications.“
We now prepare to commercially launch the products in all markets where the CE Mark is recognized. With introduction of our innovative technology products in markets, we will be able to expand treatment options for the benefit of many millions of patients with coronary and peripheral artery disease around the world.
Founded in 2017, L2Mtech GmbH is a privately-owned multinational medical device company headquartered at Bonn, Germany. L2Mtech specializes in design, development, manufacture and commercialization of medical devices that are used by healthcare establishments globally. L2MTech will provide interventional physicians with innovative vascular devices including Drug Eluting Balloon manufactured in Europe.Our Core mission is to build a product portfolio focused on minimally invasive treatment for patients with cardiovascular,endovascular and vascular artery disease. For further information, please visit : L2MTech.de
+49 228 94730761
FUTURE OF HEALTHCARE
Ensemble Health Partners | December 15, 2021
Ensemble Health Partners, in partnership with Caduceus Capital Partners, led the $8 million Series A capital raise for Janus Health, a revenue cycle automation and decision support platform.
Billions of dollars are left uncollected annually by healthcare providers due to poor methods and inconsistent human decision making in the revenue cycle process. Janus Health studies end-user behavior within the revenue cycle and uses advanced AI to determine the optimal path for each workflow. Janus then automates processes and end-to-end workflows using its scalable platform and delivers real-time predictive recommendations to guide human worker performance.
“I invest in people first. I’ve known Brendan for a long time, and he has assembled an incredible team who are experts in the field. We see a lot of technology fads in healthcare, but I am always most concerned with delivering value and creating a meaningful impact for our clients and associates. As someone deeply entrenched in the revenue cycle world, I see tremendous potential for Janus to deliver on both fronts.”
Judson Ivy, Founder, President and CEO, Ensemble Health Partners
“Several factors, including labor shortages, shrinking reimbursements and more stable IT environments, are creating a ripe opportunity to transform the revenue cycle with artificial intelligence and automation,” said Brendan Downing, co-founder and CEO of Janus Health. “Janus Health offers a timely service that can have a significant impact for health systems struggling with these rising costs-to-collect and reimbursement challenges.”
Health systems continue to struggle with a workforce shortage and lack of resources. A recent McKinsey & Company study showed that $180 billion could be saved in healthcare administration and finance costs with automated technology. Many health systems do not currently have revenue cycle automation, but plan to implement this technology in the next year. With Janus Health, managers and executives receive actionable insights into people, productivity and practices, allowing them to optimally allocate and manage resources.
“The revenue cycle in healthcare is notoriously challenging. Billing and collections are especially complicated when you consider the various payors and parties involved in a transaction,” said Dave Vreeland, senior managing partner at Caduceus Capital Partners. “This area is one of the most labor-intensive in healthcare, and there is a huge opportunity for Janus to make a difference in the industry.”
Jim Gaffney, EVP, strategy and corporate development at Ensemble Health Partners and Sue Tyler, venture partner at Caduceus Capital Partners will serve on the Janus Health board of directors.
About Ensemble Health Partners
Ensemble Health Partners is a leading provider of technology-enabled revenue cycle management solutions for health systems, including hospitals and affiliated physician groups. The company offers end-to-end revenue cycle solutions as well as a comprehensive suite of point solutions to clients across the country.
About Caduceus Capital Partners, LLC
Caduceus Capital Partners is a venture capital and private equity company focused on early-stage digital health investments. The Caduceus Capital Partners investment model actively supports portfolio companies from the first check to the exit phase with operational expertise and network access to potential customers and partners.
About Janus Health Technologies
Janus Health is leapfrogging the automation solutions of today by developing the only end-to-end process improvement platform that studies a revenue cycle operation to determine the optimal path of each workflow and rapidly builds intelligent automation and decision support with a single-click.