Tag: M2S

West Lebanon, NH Oct 13, 2015 – M2S®, Inc., a leader and innovator in technology for quality improvement in healthcare has now completed over 300,000 high quality cardiovascular 3D reconstructions for clients. M2S has provided cardiovascular imaging services and Preview® surgical planning software to over 400 hospitals and 1,000 vascular surgeons and surgical teams, both in the United States, and internationally.
Preview has helped to revolutionize the way in which cardiovascular disease is evaluated, treated and monitored. It provides specialized hyper-accurate measurements, provides treatment planning assistance, and is an integral part of the follow up surveillance and long-term care for high-risk patients. The images received for 3D Preview reconstruction and clinical trial assessment are primarily CT’s, but MRA’s, X-rays and ultrasounds are also used to develop the most comprehensive 3D reconstruction of the relevant anatomy. The average data set provided to M2S for Preview purposes is approximately 1,000 images, resulting in a database of close to 300 million individual medical images.
Founded in 1997, M2S (previously Medical Media Systems, Inc) started as a small R&D firm. In 2000, Preview was granted approval from the FDA as a Class II medical device, which allowed the company to begin providing products and services on a commercial basis. The usage of Preview has grown in the vascular medical community, and the 300,000 Preview reconstructions have been created over a span of 15 years.
Greg Lange, President and CEO at M2S, says “From the initial development of devices for EVAR, M2S has been helping surgeons with cardiovascular case planning and patient surveillance. Our Preview product and PEMS system provide exceptional tools for understanding the patient’s unique anatomy, visualizing graft placement, determining the best treatment plan and managing patients over time. We are incredibly proud to have touched this many lives and enabled the best clinical outcomes.”
Many vascular surgeons are long-term Preview users, and have integrated it into their case planning year after year. “M2S has always provided a high quality product enabling long term surveillance projects, such as SVS VQI, and other critical study support including core lab analysis,” said Dr. Rod White, who has been using M2S since its inception. “We rely on the data provided by M2S for routine clinical care and surveillance, and have benefited by having complex case planning provided to support commercial and Physician Sponsored IDE development and data analysis. I am also impressed by the level of dedication and expertise demonstrated by the M2s employees – consistently reliable and always focused on patient care.”

Chicago, IL and West Lebanon, NH Sep 16, 2015 – The Society of NeuroInterventional Surgery® (SNIS) and M2S®, a leading clinical registry provider, are pleased to announce the launch of the new Cerebral Aneurysm module for the NeuroVascular Quality Initiative (NVQI®), and the planned launch for the Cerebral Arteriovenous Malformations (AVMs) module in early October. The development of these web-based quality modules significantly broadens the scope of NVQI, and, together with the existing Acute Ischemic Stroke module, will provide new insights into outcomes and the efficacy of different NeuroInterventional therapies. The NVQI is the first clinical registry to focus exclusively on all aspects of neurovascular care.
The NVQI has already enrolled several facilities across five states and captured over 120 procedures. Additional contracts are in process for all three modules. Some of the current participating centers include the Cleveland Clinic, Erlanger Medical Center, Cadence Health Central DuPage Hospital, Novant-Forsyth Medical Center and Baylor University Medical Center at Dallas. Future NVQI modules are planned for 2016.
“To drive the quality improvements essential for our profession and for our patients, we need detailed outcomes data that only a registry designed for NeuroInterventional procedures can provide for us. The NVQI will be instrumental in building greater understanding of different patient populations and best practices as we start to tap into this valuable data source,” said Charles J. Prestigiacomo, MD, Medical Director of the SNIS Patient Safety Organization.
The NVQI has been designed to track key outcomes to demonstrate areas for clinical improvement. NVQI centers can compare processes, complication rates, and length of stay as well as medical device effectiveness. Specifically, NVQI is designed to support individual neurointerventionalists and hospitals by driving better understanding of outcomes and developing best practice in neurovascular surgery.
M2S has been working with the SNIS as their registry technology partner, and hosts the NVQI. All data are securely stored within the M2S PATHWAYS quality improvement data platform. All three NVQI modules track and measure individual procedures, as well as benchmark variation among different physicians and different centers and provide drill-down capabilities.
Betti Kerrigan, VP of Sales and Marketing for M2S, adds, “Use of M2S PATHWAYS will allow NVQI members to collect and analyze procedure data in greater detail, in real time. Together, PATHWAYS and NVQI can help hospitals and clinicians track neurovascular outcomes so they can drive quality and reduce costs.”

Chicago, IL and West Lebanon, NH Jun 24, 2015 – The Society for Vascular Surgery® Patient Safety Organization and M2S, a leader in clinical registry development, today announced a new observational registry collaboration with Vascular Flow Technologies Ltd (UK). The SVS PSO Spiral Flow Technology AV Access Registry (STAAR) will be developed within the Vascular Quality Initiative® (VQI) using the M2S PATHWAYS clinical platform.
The SVS PSO evaluation of Vascular Flow Technology’s Spiral Laminar Flow™ Arteriovenous Graft will objectively measure the long-term safety, efficacy and cost effectiveness when used as the primary access for patients with end stage renal disease (ESRD) requiring routine hemodialysis. The STAAR project will recruit up to 15 participating centers in the US and enroll up to 75 patients with ESRD who require synthetic graft placement for hemodialysis access. Patients will be followed for a period of up to 12 months following graft implantation. The STAAR post market registry will collect intraoperative and acute post-operative outcomes in addition to long term graft performance in real world clinical practice as patients undergo routine dialysis. Experienced Data and Project Management teams from M2S have been chosen by the SVS PSO to support this project. An SVS PSO appointed Steering Committee, chaired by Richard Neville, M.D., will oversee the project, analysis, and publication of results. Sites will be selected to participate in this quality improvement project based on their volume of Hemodialysis Access procedures and interest in collecting additional procedure and follow-up data. Participating sites will be reimbursed for the expense of entering additional data for this project which allows sites to offset the cost of
participating in VQI.
Greg Lange, President and CEO of M2S, adds, “By leveraging the Vascular Quality Initiative platform, M2S’ experience managing clinical projects and the SVSPSO’s clinical oversight, VFT can observe real world performance of their Spiral Flow Graft in an efficient and unbiased manner. M2S is eager to support VFT in this effort and advance our mission to improve healthcare quality.”
Dr. Barbara Bunger, Chief Clinical Officer for Vascular Flow Technologies, commented: “We anticipate the STAAR dataset to help confirm existing studies showing Spiral Flow™ grafts have higher patency rates, and require fewer interventions than PTFE grafts resulting in lower costs to healthcare payers and healthcare providers.”

Chicago, IL and West Lebanon, NH Jun 24, 2015 – M2S, Inc., a leader in providing clinical outcomes data, and the Society for Vascular Surgery’s Vascular Quality initiative® (SVS VQI) have been chosen by the principal investigators for the CREST-2 Randomized Control Trial (RCT) to collect procedural data and reports for this project. M2S, as the exclusive registry provider to the SVS VQI, will be contracting with sites for the associated CREST-2 Registry, which will monitor volumes of carotid artery stent (CAS) procedures performed by potential CREST-2 interventionists until they achieve the minimum volume and quality to join the CREST-2 RCT. The VQI CAS Registry is already providing this support to VQI members who intend to participate in CREST-2, through current or previously entered cases. Centers with interventionists who wish to participate in CREST-2 but are not yet members of VQI may join the CAS Registry. Retrospective procedure entry as far back as September 17, 2014 can be reported for this project.
After sites are approved for the RCT, they will be required to continue to enter data into the VQI CAS Registry for patients who undergo CAS but are not included in the RCT. Participation in CREST-2 Registry and RCT allows sites to be reimbursed by CMS for CAS procedures in asymptomatic patients or lower risk symptomatic patients for whom Medicare coverage is not otherwise available
About the CREST-2 Trial
The CREST-2 Trial goals are to compare medically managed patients versus Carotid Endarterectomy and to compare medically managed patients versus carotid artery stent procedure. CREST-2 will enroll a maximum of 2,480 participants at 120 medical centers across the United States and Canada. The physicians will be chosen to participate in CREST-2 based on their previous experience and are skilled at performing the procedure, based on a rigorous credentialing process which includes evaluating results from the CREST-2 Registry.
CREST-2 is sponsored by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health. CREST-2 is designed to compare three different methods of stroke prevention to find the safest and most effective treatment for patients with narrowing of their carotid arteries. The stroke prevention methods include intensive medical management alone compared to intensive medical management in combination with a procedure to reopen the carotid artery for treatment of plaque buildup. The two procedures available in this study are carotid endarterectomy and carotid artery stenting. All participants will receive intensive medical management to help control their risk factors for stroke. CREST2 is co-sponsored by the Mayo Clinic and University of Maryland.
University of Maryland Training
Potential operators must undergo the web-based training program for the CREST-2 CAS protocol prior to enrolling patients into CREST-2 Registry. The University of Maryland Team will conduct these training and can be contacted at C2R@smail.umaryland.edu. Contact the University of Maryland team for any questions regarding Medicare reimbursement. More information may be found at:
http://www.cms.gov/Medicare/Medicare‐General‐Information/MedicareApprovedFacilitie/Carotid‐Artery‐Stenting‐CAS‐Investigational‐Studies.html
About the Vascular Quality Initiative (VQI)
The VQI was launched in 2011 by the Society for Vascular Surgery and M2S to improve the quality, safety, effectiveness and cost of vascular healthcare (www.svsvqi.org). It consists of web-based clinical data registries with real-time reporting capability that allows centers to anonymously compare their patients, processes of care and procedure outcomes with others. The VQI has important features that distinguish it from other national data registries, organized as a Patient Safety Organization, which allows providers to submit all outcomes without fear of reprisal. The VQI audits claims data submitted by members to insure that all procedures are submitted, to ensure 100% reporting. The VQI also includes one year follow-up to assess both early and late results. Finally, centers in VQI are organized into regional groups that meet semi-annually to discuss variation in regional processes and outcomes, in order to design and implement regional quality improvement projects. For more information about the VQI, visit www.svsvqi.org.

Chicago, IL and West Lebanon, NH Jun 17, 2015 – Medstreaming, a leading medical informatics company specializing in workflow productivity technology and M2S Inc., a leader and innovator in technology for quality improvement in healthcare, announced the formation of a strategic licensing relationship to develop automated transfer of structured data to the Vascular Quality Initiative (VQI) Registry at the annual Society of Vascular Surgery (SVS) meeting June 17-20, 2015. Using the Medstreaming Clinical Data Management echo system for structured data aggregation, Medstreaming and M2S are focused on revolutionizing data capture and reporting for outcomes analysis.
The licensing agreement will allow hospitals, outpatient facilities, and vein centers who are participating in VQI Registries to significantly improve their data entry workflow and efficiency. Medstreaming’s workflow solution software will automate the capture of structured data elements on the web-based PATHWAYS form for the registry, including patient demographics and history, procedure details and follow-up.
Jeff Lord, Chief Technology Officer at M2S, says “Effective workflow integration is essential for the clinical registries on the PATHWAYS platform in order to streamline the data entry process for our clients. Our initial focus with Medstreaming will be on the integration for the Varicose Vein Registry. This will both strengthen the PATHWAYS platform and help our clients to capture the quality data they need to track outcomes.”
“Our collaborative effort with M2S and this innovative integration is designed to lower the costs associated with data capture and data aggregation in hospitals and outpatient offices”, said Wael Elseaidy, Medstreamings Co-Founder and CEO. “Through the use of specialty based workflow technology, we intend to significantly reduce the need for manual data entry while at the same time increasing the quality of the information transferred to the PATHWAYS Registry. This is something our clients have been asking us to accomplish for quite some time and we intend to deliver this additional value through our new strategic partnership with M2S,” said Elseaidy.

Chicago, IL and West Lebanon, NH May 28, 2015 – The Society for Vascular Surgery (SVS) and M2S, Inc., a leader in providing clinical outcomes data, have announced today that M2S has been accepted as a Qualified Clinical Data Registry (QCDR) by the Centers for Medicare and Medicaid Services (CMS). M2S, as the exclusive registry provider to the SVS Vascular Quality Initiative (VQI), has provided information on quality reporting to CMS on behalf of VQI participating physicians since 2009. The Physician Quality Reporting System (PQRS) is a CMS program that uses payment adjustments to promote the reporting of quality information by providers. In the past, this has provided a bonus payment to physicians who satisfactorily reported quality measures, but going forward, it will impose a penalty on those who fail to report. The importance of the new QCDR program is that it allows the SVS and M2S to develop additional vascular quality measures that can be used by physicians with different practice profiles to report their quality.
PQRS was originally designed to improve quality of care by initially rewarding physicians for simply reporting quality measures. Effective with 2015 reporting for 2017 payment adjustments, it has transitioned into a penalty only phase for failure to report quality measures, and eventually it will reward or penalize physicians based on quality performance, not just for reporting. VQI data has been used by its members since 2011 to improve quality, reduce variation and reduce costs. It is aligned with the CMS goals of PQRS reporting, and the acceptance of M2S as a Qualified Clinical Data Registry will provide additional opportunities for VQI participants to demonstrate their commitment to quality and value going forward.
During the past year, SVS Quality and Performance Measures Committee has worked with VQI members and M2S to create 15 new quality measures that assess appropriate care of patients with carotid, aortic, lower extremity and venous disease. Combined with 8 existing vascular PQRS measures, this creates a total of 23 potential quality measures for physicians who treat vascular disease, making it more likely that they can meet their PQRS reporting requirements. Physicians who fail to report will be at risk for reductions in their Medicare payments of 2% in 2017 based on their 2015 quality reporting. The new QCDR measures report not only immediate in-hospital outcomes, but also outcomes during one year follow-up, such as appropriate imaging after endovascular aortic aneurysm repair. This is the first example of the use of longer term outcome measures for PQRS reporting, which is only possible because of the one-year follow-up data collected in VQI. Long-term outcomes are critical to the assessment of vascular treatment, and create a unique opportunity for physicians and centers who participate in VQI.

Chicago, IL and West Lebanon, NH Apr 28, 2015 – M2S, Inc., a leader and innovator in technology for quality improvement in healthcare and SonoSoft, a leader in business continuity software and services, have committed to reduce registry data entry time for the new Vascular Quality Initiative(VQI) Varicose Vein Registry. SonoSoft will provide electronic medical records (EMR) integration for the M2S PATHWAYS™ platform, allowing collection of more comprehensive data for improved patient care.
This licensing agreement will allow vein centers, hospitals and outpatient facilities who are participating in the VVR to significantly improve their data entry workflow and efficiency. SonoSoft’s EMR software will automate the data capture of over 150 data fields on the web-based PATHWAYS form for the registry, including patient demographics and history, procedure details and follow-up.
Jeff Lord, Chief Technology Officer at M2S, says “Effective EMR integration is essential for the clinical registries on the PATHWAYS platform in order to streamline the data entry process for our clients. Our work with SonoSoft on the integration for the Varicose Vein Registry will both strengthen the PATHWAYS platform and help our clients to capture the quality data they need to track outcomes.”
SonoSoft provides an automated process for uploading the data required for the M2S PATHWAYS platform and the Varicose Vein Registry. By linking the M2S PATHWAYS clinical registry functionality with SonoSoft’s EMR functionality, staff and physicians can improve both the quality of care and efficiency. Vein specialist electronic medical records can be shared with other physicians and can conform to standards for medical billing with insurance companies as well.
Dr. John Stahl, President of Empower Technologies, adds,”We have developed a nice interface with the M2S PATHWAYS platform, so that the information in our EMR will populate the 150+ data fields for the registry in a single click and can be uploaded to the website. We feel that this improves workflow as well as the desire to continue to participate in the registry without compromising data accuracy. It’s a win/win for everyone.”

SVS PSO’s Vascular Quality Initiative® now includes 300 Centers on M2S PATHWAYS platform
Chicago, IL and West Lebanon, NH Oct 27, 2014 – 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 Society for Vascular Surgery Patient Safety Organization® and the American Venous Forum® launch new VQI® Varicose Vein Registry™
Chicago, IL and West Lebanon, NH Jan 13, 2015 – The American Venous Forum (AVF) and the Society for Vascular Surgery Patient Safety Organization (SVS PSO) have collaborated to launch a new Varicose Vein Registry® (VVR) for the Vascular Quality Initiative (VQI). Participants will have access to user-customized reports that include anonymous benchmark comparison with other regional and national centers, and participation in regional quality group meetings to develop quality improvement projects. The SVS PSO Venous Quality Committee will analyze and compare different treatment options for differing varicose vein characteristics, in order to make recommendations regarding optimal patient and treatment selection. In addition, M2S Inc, the technology partner for the VQI, is working with vendors of EMR software systems to develop integration of their system with the VQI VVR to optimize data entry efficiency. The Registry already has contracts with 13 institutions, including both hospitals and outpatient vein centers.
Participation in the VQI allows PQRS reporting and meets the needs for maintenance of board certification and IAC vein center accreditation. The VQI has also partnered with the FDA and industry to provide a registry-based method to perform post-approval surveillance of new medical devices. The VQI VVR will allow evaluation of new treatment modalities for varicose veins, which will benefit patients, physicians, the FDA, and manufacturers of devices used to treat varicose veins.
The AVF Varicose Vein Steering Committee has developed the VQI VVR, and Chairman Jose Almeida, M.D., commented: “We need an efficient, manageable, low-cost registry that can be used by every vein center in the U.S. to meet the needs of IAC accreditation. It should interface with our vein center electronic record so we can avoid double data entry, but have access to benchmark reporting that allows us to improve our practice.”
The VVR incorporates the required CEAP and VCSS measures, and allows users to easily record different treatment modalities, including specific devices used for treatment. Committee member Thomas Wakefield, M.D., summarizes the effort: “We designed an efficient, practical registry to capture key data, including patient reported outcomes and complications. It will allow us to compare the efficacy of different treatment types and provide vein centers the data they need to improve outcomes and meet regulatory requirements.”
The VQI now includes 320 centers in 46 states, organized into 18 regional quality groups. This rapid growth has been due to a user-friendly system for data entry and reporting, created by M2S, Inc., and the availability of granular comparative data, including risk adjusted outcome and efficiency measures, which provide actionable information not otherwise available to participating centers. Importantly, VQI is available to any physician specialty type who performs procedures in a center, and has become a representative, multi-specialty group. The American Venous Forum, the Society for Interventional Radiology and the Society for Vascular Medicine endorse the VQI.

The Society for Vascular Surgery Patient Safety Organization® and the American Venous Forum® launch new VQI® Varicose Vein Registry™
Chicago, IL and Milwaukee, WI Jan 13, 2015 – The American Venous Forum (AVF) and the Society for Vascular Surgery Patient Safety Organization (SVS PSO) have collaborated to launch a new Varicose Vein Registry® (VVR) for the Vascular Quality Initiative (VQI). Participants will have access to user-customized reports that include anonymous benchmark comparison with other regional and national centers, and participation in regional quality group meetings to develop quality improvement projects. The SVS PSO Venous Quality Committee will analyze and compare different treatment options for differing varicose vein characteristics, in order to make recommendations regarding optimal patient and treatment selection. In addition, M2S Inc, the technology partner for the VQI, is working with vendors of EMR software systems to develop integration of their system with the VQI VVR to optimize data entry efficiency. The Registry already has contracts with 13 institutions, including both hospitals and outpatient vein centers.
Participation in the VQI allows PQRS reporting and meets the needs for maintenance of board certification and IAC vein center accreditation. The VQI has also partnered with the FDA and industry to provide a registry-based method to perform post-approval surveillance of new medical devices. The VQI VVR will allow evaluation of new treatment modalities for varicose veins, which will benefit patients, physicians, the FDA, and manufacturers of devices used to treat varicose veins.
The AVF Varicose Vein Steering Committee has developed the VQI VVR, and Chairman Jose Almeida, M.D., commented: “We need an efficient, manageable, low-cost registry that can be used by every vein center in the U.S. to meet the needs of IAC accreditation. It should interface with our vein center electronic record so we can avoid double data entry, but have access to benchmark reporting that allows us to improve our practice.”
The VVR incorporates the required CEAP and VCSS measures, and allows users to easily record different treatment modalities, including specific devices used for treatment. Committee member Thomas Wakefield, M.D., summarizes the effort: “We designed an efficient, practical registry to capture key data, including patient reported outcomes and complications. It will allow us to compare the efficacy of different treatment types and provide vein centers the data they need to improve outcomes and meet regulatory requirements.”
The VQI now includes 320 centers in 46 states, organized into 18 regional quality groups. This rapid growth has been due to a user-friendly system for data entry and reporting, created by M2S, Inc., and the availability of granular comparative data, including risk adjusted outcome and efficiency measures, which provide actionable information not otherwise available to participating centers. Importantly, VQI is available to any physician specialty type who performs procedures in a center, and has become a representative, multi-specialty group. The American Venous Forum, the Society for Interventional Radiology and the Society for Vascular Medicine endorse the VQI.