Tag: M2S

The Vascular Quality Initiative (VQI®) now includes over 300 participating centers dedicated to quality improvement across 45 states and Canada.
Chicago, IL and West Lebanon, NH Oct 27, 2013 – The Vascular Quality Initiative (VQI®), governed by the Society for Vascular Surgery Patient Safety Organization (SVS PSO), and designed to improve the quality of vascular healthcare, has reached a milestone with 300 participating centers. The VQI is a collaborative between the Society for Vascular Surgery® Patient Safety Organization (SVS PSO), the American Venous Forum (AVF), and the Society for Vascular Medicine (SVM) and M2S, Inc.
Through regional and national benchmarking, the SVS PSO uses data for quality improvement, collected through the M2S PATHWAYS platform, to assist physicians and data managers to better understand clinical outcomes and follow up at a unique level of detail. Participating physicians have captured over 175,000 cases across 11 different vascular procedures. The VQI is now in 45 states, includes over 2300 physicians and represents almost 21% of all centers that provide vascular interventions in the United States.
Dr. Larry Kraiss, Chair of SVS PSO Governing Council for VQI, comments, “This is a remarkable milestone for the VQI which started in 2011. The rapid enrollment in VQI by the vascular community is gratifying because it confirms an existing broad and deep commitment to quality outcomes that we always knew to be present among our colleagues. Even more exciting are the prospects for quality initiatives that are only possible because we are organized around a common data platform that allows us to develop and monitor very concrete action plans that will provide useful information for evidence-based patient management on a daily basis. “
The regional quality groups of the VQI are fundamental for driving quality initiatives at the local level that reduce length of stay, readmissions, and complications. In addition to improving quality within hospitals, the VQI supports vascular research and works with device companies to support post-market device surveillance projects.
Greg Lange, President and CEO of M2S, adds “The VQI continues to increase its value to providers, hospitals and industry through expanded reporting and analytics, improved support for hospital quality improvement initiatives and innovative partnerships with the FDA and
Industry. Surpassing 300 centers is a major milestone which reflects the strong commitment to quality improvement and cost containment within the vascular community.”
In the latest developments, the SVS PSO and M2S are pioneering the use of VQI data for post- approval surveillance in vascular surgery in place of the traditional recruitment of sites by medical device companies. This approach allows for faster and less expensive recruitment of sites, and is strongly encouraged by the FDA.
The newest registry, focusing on the treatment of Varicose Veins, will be released in December 2014. For more information on the Vascular Quality Initiative, please go to www.vascularqualityinitiative.org

The NeuroVascular Quality Initiative™ (NVQI™) Launches First Procedure Module: Acute Ischemic Stroke
Chicago, IL and West Lebanon, NH Oct 25, 2014 – The Society of NeuroInterventional Surgery (SNIS) and M2S announce the launch of the NeuroVascular Quality Initiative™ (NVQI™), a multi-module registry system designed to track performance and outcomes data across a variety of neurovascular conditions. The launch debuts the Acute Ischemic Stroke (AIS) module, which will be used to track and benchmark clinical performance at the center level and nationally, providing valuable insight into the effectiveness of endovascular interventions and associated devices in treating a condition known to be the nation’s fourth leading cause of death. As of today, NVQI is officially enrolling hospitals and specialists in the AIS module.
As neurointerventional procedures (minimally invasive techniques designed to treat endovascular conditions of the brain and spine), have changed the treatment landscape over the past two decades and offered thousands of patients quality treatment alternatives to traditional medical approaches, NVQI is designed to track the success of these procedures, as well as demonstrate areas for improvement. Specifically, NVQI will collect detailed data on:
• Patient demographics including age, weight/height, and co-morbidities
• Patient history including pre-op medications, pre-stroke status and key time metrics associated to patient arrival and imaging
• Procedure details including treatments and devices used and medications given
• Follow-up including 14 day, 30 day, month and 1 year follow up
NVQI will be governed by the SNIS Patient Safety Organization (SNIS PSO), which oversees the data sharing arrangements and patient safety initiatives conducted within the NVQI. The importance of the PSO structure is that it protects all comparative analyses generated within the PSO from legal discovery in state and federal court. Furthermore, it permits the collection of patient identified data for quality improvement purposes without requiring consent from individual patients or prior approval from an Institutional Review Board.
“By encouraging the collection, aggregation, benchmarking, and analysis of clinical data, NVQI will assist SNIS members in understanding and improving patient outcomes in a safe environment. NVQI will also permit tracking of new devices and device efficacy in a real world setting which is a critical need within this evolving field,” said Peter Rasmussen, MD, Medical Director of SNIS PSO.
Gregory Lange, CEO of M2S, adds, “The NVQI Registry, supported by the M2S PATHWAYS platform, can provide, for the first time, both the breadth and depth of real time clinical data to assist hospitals and quality departments, as well as physicians, improve care for stroke patients.
Looking forward, the SNIS PSO is already planning its next-stage launch of two modules dedicated to cerebral aneurysms and cerebral arteriovenous malformations, scheduled for later this year. Additional considerations for modules include diagnostic angiography and spinal disease.
SNIS PSO has chosen M2S as the technology vendor to host the NVQI. All data will be securely stored within the M2S PATHWAYS quality improvement data platform. M2S specializes in cloud-based quality improvement registries for data collection and reporting, offering several unique features designed to maximize reporting as well as ease of use by specialists enrolled in registries hosted on M2S PATHWAYS.

Lombard Medical Engages Society for Vascular Surgery® and M2S Inc. to Implement Post-Marketing Surveillance Program for Aorfix™ Endovascular Stent Graft
West Lebanon, NH Sep 24, 2013 – Lombard Medical, Inc. (NASDAQ: EVAR), a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA), has partnered with the Society for Vascular Surgery® Patient Safety Organization (SVS PSO) and M2S Inc. to develop a FDA-required post- marketing surveillance program for Aorfix™, an endovascular stent graft to treat AAA. Lombard Medical will use the Vascular Quality Initiative® (VQI) Endovascular AAA Registry™, the PATHWAYS™ cloud-based data platform and M2S Preview 3D modelling to track outcomes in patients treated with Aorfix at up to 50 VQI centers nationwide. Aorfix has been used to treat more than 3,000 patients worldwide since it first received regulatory approval.
AAA affects 200,000 Americans each year, and occurs when a weak area of the abdominal aorta expands and is at risk of rupture, and death, if left untreated. AAA is treated by the placement of an endovascular stent graft, such as Aorfix, into the area of the aneurysm to strengthen the weakened wall of the abdominal aorta. The FDA requires post-market surveillance of any device intended to be implanted in the body for more than a year.
The surveillance program will consist of reporting from multiple centers on a non-randomized basis. Freedom from aneurysm-related mortality will be assessed at 5 years following the initial procedure in approximately 234 patients.
Dr. Jack L. Cronenwett, Medical Director for the Society for Vascular Surgery® Patient Safety Organization, states, “We have been working with Lombard Medical, M2S and the FDA to construct a post-approval surveillance program which integrates clinical registry data on patient outcomes after endovascular AAA repair with 3D CT scan imaging for detailed device monitoring. This quality improvement initiative will collect data and follow-up time points for patients in VQI and analyze these data along with image data for quality improvement purposes within the SVS PSO. In addition, non-identifiable data from this project will be shared with the FDA and Lombard Medical to satisfy post-approval surveillance requirements.”
Lombard Medical CEO Simon Hubbert said, “We could not have chosen better partners to collaborate with on this post-market surveillance program, and we are extremely confident that Aorfix will continue to show superior clinical results in both challenging ‘high neck angle’ anatomy and more easily treatable AAA patients. We look forward to working with SVS and M2S in support of this post-market surveillance program.
Gregory Lange, President and CEO of M2S, Inc., added, “By combining the VQI clinical quality data and quantitative anatomic information from M2S’ Preview imaging services, Lombard Medical and the FDA will have a complete picture of the patients being treated, their anatomy, the performance of Lombard’s graft and the clinical outcomes. This is a significant development in the monitoring of endovascular aortic aneurysm performance post- approval.”
The Vascular Quality Initiative
The Vascular Quality Initiative® is a distributed network of regional groups that use the Society for Vascular Surgery Patient Safety Organization and the M2S cloud based system to collect and analyze data to improve the quality of vascular health care. Through regional quality group meetings, VQI participants share data to develop quality improvement projects designed to standardize processes, improve outcomes, and reduce complications and costs. Currently the VQI includes 11 registries including the Endovascular AAA Registry.

W.L. Gore and Associates to leverage the Vascular Quality Initiative® to meet post-approval study requirements using the M2S PATHWAYS™ data and analytics platform. Over 280 participating hospitals have contributed the results of over 136,000 procedures to the Society for Vascular Surgery’s Vascular Quality Initiative®
West Lebanon, NH Apr 29, 2013 – M2S Inc., a leader in software-as-a-service for clinical quality improvement, today announced a ground-breaking joint initiative with the Society for Vascular Surgery® Patient Safety Organization and two aortic stent manufacturers to meet post-approval studies (PAS) requirements in the treatment of type B aortic dissections. Aortic Dissections are a serious cardiovascular condition associated with high morbidity and mortality in which the upper segment of the body’s main artery has become torn along the innermost layer of the vessel wall. Gore and one other manufacturer will leverage the Vascular Quality Initiative® (VQI®), which is powered by the M2S PATHWAYS™ clinical data performance platform, a cloud-based quality improvement registry for data collection, reporting, and collaboration.
The Conformable GORE® TAG® Thoracic Endoprosthesis is an FDA approved device on the market in the US. Approval was recently broadened to include treatment of chronic and non- complicated dissection, with the provision that the efficacy of TEVAR treatment of descending aortic dissection would be more fully analyzed through post-market study. This observational study is expected to collect 200 acute and 200 chronic dissection procedures, with 5 year follow-up. The use of real-time clinical registry data from the VQI® will increase the efficiency of executing a post-approval study, while improving the ability to provide real-world feedback.
Dr. Jack L. Cronenwett, Medical Director for the Society for Vascular Surgery® Patient Safety Organization, states, “For the past year, representatives of the SVS PSO, FDA, industry, M2S and scientific advisors from surgical societies have met to discuss the value of using registry data to measure the safety and efficacy of TEVAR treatment of aortic dissection. Based on these discussions, the SVS PSO is pleased to announce this voluntary quality improvement initiative that will collect additional data and follow-up time points for patients in VQI® who are treated for acute or chronic descending thoracic aortic dissection. These data will be analyzed and used for quality improvement purposes within the SVS PSO, and non-identifiable data from this project will be shared with the FDA and device manufacturers, to meet the needs of their post approval study requirement.”
Gregory Lange, President and CEO of M2S, Inc., adds, “We are thrilled to collaborate with the SVS, FDA and industry to help evaluate the safety and efficacy of new devices in real-world practice. We expect this to be the first of many opportunities to support industry through the use of the M2S PATHWAYS platform and the VQI®, and to support our mutual goal of improvement in vascular health care.”

The NeuroVascular Quality Initiative™ (NVQI™) Launches First Procedure Module: Acute Ischemic Stroke
West Lebanon, NH Mar 25, 2013 – The Society of NeuroInterventional Surgery (SNIS) and M2S announce the launch of the NeuroVascular Quality Initiative™ (NVQI™), a multi-module registry system designed to track performance and outcomes data across a variety of neurovascular conditions. The launch debuts the Acute Ischemic Stroke (AIS) module, which will be used to track and benchmark clinical performance at the center level and nationally, providing valuable insight into the effectiveness of endovascular interventions and associated devices in treating a condition known to be the nation’s fourth leading cause of death. As of today, NVQI is officially enrolling hospitals and specialists in the AIS module.
As neurointerventional procedures (minimally invasive techniques designed to treat endovascular conditions of the brain and spine), have changed the treatment landscape over the past two decades and offered thousands of patients quality treatment alternatives to traditional medical approaches, NVQI is designed to track the success of these procedures, as well as demonstrate areas for improvement. Specifically, NVQI will collect detailed data on:
Patient demographics including age, weight/height, and co-morbidities
Patient history including pre-op medications, pre-stroke status and key time metrics associated to patient arrival and imaging
Procedure details including treatments and devices used and medications given
Follow-up including 14 day, 30 day, month and 1 year follow up
NVQI will be governed by the SNIS Patient Safety Organization (SNIS PSO), which oversees the data sharing arrangements and patient safety initiatives conducted within the NVQI. The importance of the PSO structure is that it protects all comparative analyses generated within the PSO from legal discovery in state and federal court. Furthermore, it permits the collection of patient identified data for quality improvement purposes without requiring consent from individual patients or prior approval from an Institutional Review Board.
“By encouraging the collection, aggregation, benchmarking, and analysis of clinical data, NVQI will assist SNIS members in understanding and improving patient outcomes in a safe environment. NVQI will also permit tracking of new devices and device efficacy in a real world setting which is a critical need within this evolving field,” said Peter Rasmussen, MD, Medical Director of SNIS PSO.
Gregory Lange, CEO of M2S, adds, “The NVQI Registry, supported by the M2S PATHWAYS platform, can provide, for the first time, both the breadth and depth of real time clinical data to assist hospitals and quality departments, as well as physicians, improve care for stroke patients.
Looking forward, the SNIS PSO is already planning its next-stage launch of two modules dedicated to cerebral aneurysms and cerebral arteriovenous malformations, scheduled for later this year. Additional considerations for modules include diagnostic angiography and spinal disease.
SNIS PSO has chosen M2S as the technology vendor to host the NVQI. All data will be securely stored within the M2S PATHWAYS quality improvement data platform. M2S specializes in cloud-based quality improvement registries for data collection and reporting, offering several unique features designed to maximize reporting as well as ease of use by specialists enrolled in registries hosted on M2S PATHWAYS.

The NeuroVascular Quality Initiative™ (NVQI™) Launches First Procedure Module: Acute Ischemic Stroke
West Lebanon, NH MAR 26, 2013 – The Society of NeuroInterventional Surgery (SNIS) and M2S announce the launch of the NeuroVascular Quality Initiative™ (NVQI™), a multi-module registry system designed to track performance and outcomes data across a variety of neurovascular conditions. The launch debuts the Acute Ischemic Stroke (AIS) module, which will be used to track and benchmark clinical performance at the center level and nationally, providing valuable insight into the effectiveness of endovascular interventions and associated devices in treating a condition known to be the nation’s fourth leading cause of death. As of today, NVQI is officially enrolling hospitals and specialists in the AIS module.
As neurointerventional procedures (minimally invasive techniques designed to treat endovascular conditions of the brain and spine), have changed the treatment landscape over the past two decades and offered thousands of patients quality treatment alternatives to traditional medical approaches, NVQI is designed to track the success of these procedures, as well as demonstrate areas for improvement. Specifically, NVQI will collect detailed data on:
Patient demographics including age, weight/height, and co-morbidities
Patient history including pre-op medications, pre-stroke status and key time metrics associated to patient arrival and imaging
Procedure details including treatments and devices used and medications given
Follow-up including 14 day, 30 day, month and 1 year follow up
NVQI will be governed by the SNIS Patient Safety Organization (SNIS PSO), which oversees the data sharing arrangements and patient safety initiatives conducted within the NVQI. The importance of the PSO structure is that it protects all comparative analyses generated within the PSO from legal discovery in state and federal court. Furthermore, it permits the collection of patient identified data for quality improvement purposes without requiring consent from individual patients or prior approval from an Institutional Review Board.
“By encouraging the collection, aggregation, benchmarking, and analysis of clinical data, NVQI will assist SNIS members in understanding and improving patient outcomes in a safe environment. NVQI will also permit tracking of new devices and device efficacy in a real world setting which is a critical need within this evolving field,” said Peter Rasmussen, MD, Medical Director of SNIS PSO.
Gregory Lange, CEO of M2S, adds, “The NVQI Registry, supported by the M2S PATHWAYS platform, can provide, for the first time, both the breadth and depth of real time clinical data to assist hospitals and quality departments, as well as physicians, improve care for stroke patients.
Looking forward, the SNIS PSO is already planning its next-stage launch of two modules dedicated to cerebral aneurysms and cerebral arteriovenous malformations, scheduled for later this year. Additional considerations for modules include diagnostic angiography and spinal disease.
SNIS PSO has chosen M2S as the technology vendor to host the NVQI. All data will be securely stored within the M2S PATHWAYS quality improvement data platform. M2S specializes in cloud-based quality improvement registries for data collection and reporting, offering several unique features designed to maximize reporting as well as ease of use by specialists enrolled in registries hosted on M2S PATHWAYS.

M2S and the Vascular Quality Initiative® adds first venous procedure module – Inferior Vena Cava Filter – to its PATHWAYS database
West Lebanon, NH Feb 15, 2013 – M2S, the exclusive technology provider for the Vascular Quality Initiative® (VQI®), announces the release of Inferior Vena Cava (IVC) Filter procedure module to its PATHWAYS clinical data performance platform. IVC Filter is the first venous module added to the database, expanding the VQI to become the comprehensive arterial and venous registry.
With the release of IVC Filter, the VQI now monitors eleven vascular procedures through M2S’s PATHWAYS platform. In January, the VQI announced its collaboration with the American Venous Forum (AVF) to add venous interventions. This growth increases the value of benchmarking among participants and regional quality groups, and expands the scope for quality improvement and quality research projects that affect patient care. Today the VQI has more than 220 participating centers across the United States and Canada that have entered over 75,000 procedures into the PATHWAYS database.
M2S’s PATHWAYS platform provides participating centers and providers with real-time data collection and reporting tools, empowering users to collaborate on outcomes and implement quality improvement projects to impact quality and cost of vascular care. M2S, along with the AVF and Society for Vascular Surgery, plans to expand the database with additional venous procedure modules, including Venous Stenting, DVT Thrombolysis, and Upper Extremity DVT treatment.

American Venous Forum and Society for Vascular Surgery Launch Expanded Quality Initiative
West Lebanon, NH Jan 10, 2013 – The Society for Vascular Surgery® (SVS) and the American Venous Forum (AVF) are pleased to announce the expansion of the SVS Vascular Quality Initiative®(VQI) to include the treatment of venous disease. The VQI, launched by SVS in 2011, will now include both arterial and venous procedures. Data collection and analysis tools for the VQI are provided through M2S’s PATHWAYS cloud-based clinical data performance platform.
“This expansion of the VQI enhances SVS’ mission to assist its members in understanding and improving patient outcomes by encouraging the collection, aggregation, and analysis of clinical data,” said Peter Gloviczki, MD, SVS president. “As more than 20 percent of the adult population suffers from chronic venous diseases, AVF is committed to expanding its efforts through the VQI to assess the efficacy of various treatments for patients with venous disease,” according to AVF president Robert McLafferty, MD.
The partnership with M2S positions AVF and SVS as leaders in vascular quality improvement by providing a platform for their members to analyze outcomes, determine best practices, and collaborate on quality improvement efforts across regions. Currently, the VQI has more than 200 participating centers across the United States and Canada. Regional quality groups have been established throughout the United States to share and analyze the data collected by individual sites and to initiate local quality improvement projects that affect patient care.
“M2S has a long history of managing healthcare information for the purpose of improving patient care. We are excited to partner with AVF and SVS to broaden our impact on healthcare quality improvement and clinical outcomes and to ensure the continued success of the VQI through our PATHWAYS platform. We have designed PATHWAYS to meet the critical challenges in healthcare and empower physicians to analyze individual procedure outcomes along with their peers,” said Greg Lange, president and chief executive officer of M2S.

West Lebanon, NH Nov 28, 2012 – The Vascular Quality Initiative® (VQI), designed to improve the quality of vascular healthcare has reached a significant milestone by surpassing 200 participating centers. The VQI® is a joint partnership between M2S and the Society for Vascular Surgery® (SVS) Patient Safety Organization. Reaching this mark positions the VQI® as the fastest growing quality improvement database in North America since launching in February 2011
“SVS and its members strive for the highest quality in treating vascular patients,” said Peter Gloviczki, SVS President. “VQI has experienced fast growth and continued penetration in the vascular health field because it offers the tools and mechanisms to accurately measure important quality parameters and compare them to benchmarks. Outcomes are benchmarked with peers, regionally, and then applied locally to support internal quality assurance and quality improvement projects.”
In just over a year and a half since inception, the VQI has grown exponentially in not only its number of participating centers, but also in the number of physicians collecting and entering procedural and outcome data. The database accumulates an average 3,500 procedures each month, further enhancing the value of benchmarking outcomes among providers and influencing quality improvement projects and quality research.
The regional quality groups of the VQI are fundamental for driving quality initiatives at the local level that reduce length of stay, readmissions, and complications. They also are important in fostering initiatives that can lead to best practice recommendations. Recently, the Quality Committee of the VQI, which is composed of physician representatives from each of the established regional groups, analyzed in-hospital surgical site infection after infra-inguinal bypass, finding significant variation in risk-adjusted rates across participating centers. Based on the findings of this project, the committee plans to prepare a scientific manuscript and quality recommendation.

West Lebanon, NH Sep 14, 2012 – M2S, Inc., the exclusive technology provider for the Society for Vascular Surgery® Vascular Quality Initiative® announces the release of its Analytics and Reporting Engine. This new reporting tool further enhances the value of the VQI® by empowering users to perform complex analyses with just a few mouse clicks.
The Analytics and Reporting Engine sets the VQI apart, providing custom reporting capabilities to give users complete control of their data analysis. Participants of the VQI may now select variables of interest and filter their data set to a desirable patient population for specific analyses. Additionally, users are able to benchmark results with their peers for further comparison of outcomes.
The value of benchmarking improves as VQI participation continues to expand. Today there are 200 centers and over 1,000 physicians collecting data in the VQI. Regional quality groups continue to develop as well and implement quality improvement projects to affect patient care at the local level. The SVS Patient Safety Organization (PSO) plans to accredit eight new regional groups by the end of this year in addition to the ten that are currently organized.
The VQI recently reached another milestone, capturing over 3,500 new procedures each month, making this the fastest growing, validated arterial vascular registry from which to benchmark. The Analytics and Reporting Engine further enhances the control and utility of that data to improve patient care, communicate about the best practices for delivering care with attention to containing costs.