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.
Exela Technologies | January 12, 2022
Exela Technologies, Inc. (“Exela”)today announced that it continues to expand its relationship with a leading health insurance organization that spans almost two decades. This customer continues to accelerate deployment of Exela’s PCH Global platform to speed up their digital transformation and improve both the member and provider experience. The latest expansion is valued at $6.2 million of additional contract value revenue.
Exela continues to invest in expanding PCH Global’s capabilities to provide a cloud hosted solution with one of the best edit resolutions for healthcare claims. This extension of deployment marks another milestone in the value proposition of the PCH Global platform to digitally connect members, providers and insurance companies to enable clean claims, payment transparency and digital appeals. PCH Global’s cloud network also offers increased scalability, the highest uptime and best business continuity protections. PCH Global has robust data analytics which are continually improving as Exela processes more and more data. Additionally, PCH Global’s improved data analytics can be accessed via a self-service model.
“We are proud of our long standing partnership and privileged to be part of customer’s digital transformation journey. Adoption of our PCH Global platform continues to address healthcare industry’s goal to deliver most efficient, cost effective and best healthcare to the members.”
Suresh Yannamani, President of Exela
About Exela Technologies
Exela Technologies is a business process automation (BPA) leader, leveraging a global footprint and proprietary technology to provide digital transformation solutions enhancing quality, productivity, and end-user experience. With decades of experience operating mission-critical processes, Exela serves a growing roster of more than 4,000 customers throughout 50 countries, including over 60% of the Fortune® 100. Utilizing foundational technologies spanning information management, workflow automation, and integrated communications, Exela’s software and services include multi-industry, departmental solution suites addressing finance and accounting, human capital management, and legal management, as well as industry-specific solutions for banking, healthcare, insurance, and the public sector. Through cloud-enabled platforms, built on a configurable stack of automation modules, and over 17,500 employees operating in 23 countries, Exela rapidly deploys integrated technology and operations as an end-to-end digital journey partner.
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 Health | March 02, 2021
Future Health has completely rebranded during lockdown, and the flagship face-to-face event Future Health Innovations at ExCeL is now complemented by a global virtual conference series, under the brand UK Health Week. Free for delegates to attend, it is CPD and CME accredited.
Participants will be able to connect, meet buyers and partake in cross border purchasing, education and deal making, enabling an increased ROI and profitable encounters with its AI powered networking software.
Further Health Weeks are being rolled out around the world over the course of the coming months, and will be territory specific. Dawn Barclay-Ross, Event Director commented: “I think there will always be a place for face-to-face events; and we are contracted with ExCeL for a live ‘in person’ event four years in advance to 2025. However, as a result of international travel restrictions, health professionals in global markets are looking for on-line engagement”.
Future Health offers buyers and sellers the ability to operate on line, and to research and access the products and services that their hospitals and citizens desperately need.
Dawn concluded, “In the immediate post COVID era, health buyers want to be able to operate from the comfort of their desk or smart device, and they now can, from literally anywhere in the world”.
Future Health is an independent exhibition and conference organiser, based in London in the UK.
For further information regarding exhibiting, visiting and sponsorship opportunities at Future Health Innovations or UK Health Week Please call +44 (0) 208 012 8511 Email: email@example.com or to sign up to the Future Health platform, register at www.futurehealthinnovations.com