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A Case Study of Combined Perception-Based and Perception-Free Spinal Cord Stimulator Therapy for the Management of Persistent Pain after a Total Knee Arthroplasty

1 Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA USA

Mohamed Osman

Vwaire orhurhu, omar viswanath.

2 Valley Anesthesiology and Pain Consultants, Envision Physician Services, Phoenix, AZ USA

3 Department of Anesthesiology, University of Arizona College of Medicine, Phoenix, Phoenix, AZ USA

4 Department of Anesthesiology, Creighton University School of Medicine, Omaha, NE USA

Alan D. Kaye

5 Department of Anesthesiology, Louisiana State University Health Sciences Center, New Orleans, LA USA

Thomas Simopoulos

Cyrus yazdi, associated data.

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Introduction

Total knee arthroplasty (TKA) is an effective treatment modality for severe osteoarthritis of the knee. Causes of pain following TKA are poorly understood; however, patient-specific biology and various neuropathic underlying mechanisms such as neuroma formation and complex regional pain syndrome (CRPS) have been suggested. Our case demonstrated the successful treatment of CRPS in the knee with the use of combination therapy in spinal cord stimulator.

We present a 71-year-old Caucasian non-Hispanic male who presented with chronic left knee pain after undergoing a total knee arthroplasty (TKA) 18 months prior. Following his TKA, he reported doing well in the acute post-operative period but began to develop progressively worsening left knee pain at approximately the third post-operative week. He underwent a successful spinal cord stimulator (SCS) trial and subsequent implantation of two 16-contact Boston Scientific leads with a Boston Scientific Spectra WaveWriterTM SCS system. Upon first post-procedural follow-up, and moreover at his 6-month follow-up, the patient reported complete resolution of his symptoms.

The development of persistent pain following TKA is a significant complication that is often challenging to treat. Our case demonstrated the successful treatment of CRPS in the knee with the use of combination therapy in spinal cord stimulator therapy. We anticipate that more data will continue to emerge to assess for the safety and efficacy of combination therapy.

Total knee arthroplasty (TKA) is an effective treatment modality for severe osteoarthritis of the knee. Though eventual mechanical failure may be anticipated with long-term activity and normal use, as many as 28% of patients who undergo an uncomplicated TKA and postoperative course may experience persistent moderate to severe knee pain [ 1 , 2 ]. Causes of pain following TKA are poorly understood; however, patient-specific biology and various neuropathic underlying mechanisms such as neuroma formation and complex regional pain syndrome (CRPS) have been suggested [ 1 , 3 – 5 ]. Informed consent was obtained for the publication of this case. The aim of this case study is to present the use of combination spinal cord stimulator (SCS) therapy for the management of persistent pain following TKA.

Case Report

Our patient was a 71-year-old Caucasian non-Hispanic male who presented with chronic left knee pain after undergoing a TKA 18 months prior. He had an uncomplicated past medical history of hypertension, hyperlipidemia, and reflux, which were well controlled with medical management. He was 70 inches tall and weighed 215 lbs. He had no history of any additional surgeries. He was married and lived at home with his wife. He was now retired and prior to his surgery maintained an active lifestyle including exercise and daily life activities. His social history included social alcohol consumption and was negative for tobacco use (Fig.  1 ).

Anterior–posterior radiographic film demonstrating permanently implanted leads positioned at the top of the T8 vertebral body and spanning vertebra T8–T10

Following his TKA, the patient complained of persistent and progressively worsening post-operative pain of his knee. Orthopedic evaluation determined his implant to be normally functioning without evidence of hardware loosening or infection. On presentation, he described the pain as sharp, 7/10 (VAS) in severity though poorly defined, with radiation to the left ankle, and associated paresthesias in the same distribution. On physical exam, he experienced symptoms of hyperesthesia and allodynia along the anterior aspect of his knee. His postsurgical incision was well healed, without evidence of erythema, swelling, or gross changes in color. Strength was 5/5 with flexion and extension of the lower left leg, but was limited by guarding due to pain. His right lower extremity had 5/5 strength in all myotomes, and otherwise he had 5/5 strength in the left leg with flexion and extension of the thigh, inversion, eversion, plantar flexion, and dorsiflexion of his left foot.

Given his symptomatology of hyperesthesia, allodynia, preserved strength, and absence of orthopedic aberrancy, a diagnosis of postsurgical CRPS of the left lower extremity was made. Initial management of his pain was conservative including physical therapy, non-steroidal anti-inflammatory, muscle relaxant, neuropathic, and opioid medications, which provided little or no relief of symptoms. Following a trial of lumbar sympathetic block, he reported improvement in pain, with a reduction on VAS to 3/10, lasting approximately 1 month in duration. Given a dramatic improvement in his knee symptoms, he subsequently underwent a successful SCS trial and uneventful implantation of two 16-contact Boston Scientific leads with a Boston Scientific Spectra WaveWriter™ SCS system. His generator was programmed to provide simultaneous traditional paresthesia-based therapy at a frequency of 50 Hz along with the combination of burst therapy at a frequency of 450 Hz, with six pulses per burst, as well as sub perception stimulation therapy at a frequency of 1.2 kHz. Upon first post-procedural follow-up, the patient experienced dramatic pain relief, reporting complete resolution of his symptoms. Moreover, at 6 months post SCS implantation, he continued to experience complete resolution and had successfully completed an opioid wean to discontinuation.

The development of persistent pain following TKA is a significant complication that is often challenging to treat. In the absence of mechanical pathology, surgical revision for poorly defined persistent chronic pain leads to worsened outcomes [ 3 ]. Instead, a conservative approach has been demonstrated to have some benefit; in a long-term study of 18 patients who had chronic unexplained pain following surgery, 55% reported improvement with reassurance and watchful waiting at 5-year follow-up [ 6 ]. Still, few therapeutic options are available to provide relief in this challenging patient population. Our case suggests that combination therapy in SCS may be an effective modality to treat CRPS in the lower extremity. Combination SCS therapy includes both paresthesia and high-frequency sub-perception-based therapies, the combination of which is customizable to improve patient pain relief. North et al., in the WHISPER study, demonstrated supporting evidence for sub-perception therapies in combination with supra-perception therapies. They found an increased 62% patient responder rate when the combination therapy was implemented in patients with chronic pain [ 7 ]. We anticipate more data will continue to emerge and further provide supporting evidence for the safety and efficacy of combination therapy when compared to either paresthesia or sub perception-based therapies individually.

Conclusions

Persistent pain following TKA is an important complication and is often difficult to treat. Combination SCS may be an effective modality for the treatment of persistent pain in the lower extremity following TKA; further studies are needed to evaluate the long-term efficacy.

Acknowledgements

We thank the participant of the study.

No funding or sponsorship was received for this study or publication of this article.

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosures

There are no grants, sponsors, funding sources, or direct financial support to disclose. Ivan Urits, Mohamed Osman, Vwaire Orhurhu, Omar Viswanath, Alan D. Kaye, Thomas Simopoulos, and Cyrus Yazdi have nothing to disclose.

Compliance with Ethics Guidelines

Informed consent was obtained for the publication of this case.

Data Availability

Open access.

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( http://creativecommons.org/licenses/by-nc/4.0/ ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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Bots help restore work/life balance: Boston Scientific boosts efficiency and job satisfaction with robotic process automation

Client: Boston Scientific

Our Role: To help the company explore how RPA could increase the speed and accuracy of corporate tax processes, while reducing the amount of time, and overtime, spent on manual tasks.

Industry: Pharmaceutical and life sciences

Services: Tax Technology , Emerging Technology , Automation Now

Client Challenge:

Manual processes resulted in missed opportunities 

Boston Scientific was facing an all too common problem. Corporate tax and finance teams were inundated with manual tasks and working long hours, especially during peak processing times. With manual processes, too much time and effort were devoted to resolving and validating scenarios that fell outside of expected results. More importantly, the company's tax and finance professionals were spending excessive time on repetitive tasks, which kept them from leveraging their expertise and experience in strategic thinking and planning. Retaining talent was becoming a challenge. How could the company improve corporate tax and finance processes to enhance efficiency and empower their people to engage in more value-added activities? Was there a strategic way to turn around turnover?

“With the Center of Excellence in place, we’re looking at ways to leverage our experience with RPA and consider broader automation opportunities and additional technologies.” Doug Cronin, Vice President - Corporate Tax, Boston Scientific Corporation

The automation journey begins with business relevance

When Boston Scientific’s Vice President - Corporate Tax saw robotic process automation (RPA) in action at a PwC Tax conference, he realized that “digital labor” might help address critical business challenges the company was facing. RPA, an intelligent automation technology, is software that can be programmed to automate rules-based tasks, such as data entry or routine tax calculations. A team of professionals from PwC’s Tax, Advisory and Emerging Technology practices came together to help the company explore how RPA could increase the speed and accuracy of corporate tax processes, while reducing the amount of time, and overtime, spent on manual tasks.

Guided by PwC’s BXT (business, experience, technology) approach, the first leg of the intelligent automation journey was to evaluate opportunities for automation in the corporate tax function. With specific processes clearly identified, the PwC team worked closely with software partner Automation Anywhere and the Boston Scientific team to build and test the bots. They started with just a few processes, adding new ones incrementally as the bots’ effectiveness was demonstrated. Our pilot and apprenticeship activities included collaborative efforts to build the first bots and train staff how to use the RPA tools. PwC teams created and delivered the customized training curriculum, Automation Anywhere provided the library of software code and Boston Scientific teams worked alongside them both to build the bots.

After a successful pilot phase—the bots had demonstrated they could reduce manual task time by as much as 85%—the company opted to scale their efforts to the rest of the finance function. They also sought PwC’s help in setting up an RPA Center of Excellence (CoE) to support the scale-up effort. With a clear understanding of both the significant benefits, as well as the challenges, associated with creating and implementing RPA, the CoE will help identify and implement processes suitable for automation business-wide (such as developing toolsets and training materials and designing governance models) to drive strategic value going forward.

“It’s exciting to see tax and finance professionals embracing RPA as part of a larger strategic vision that can impact the whole enterprise.” Michelle Lee, PwC Tax Partner

Bots crush the timeline with an 85% reduction in time spent on manual tasks

The numbers tell a powerful story about automation’s impact on the company: 20 complex tax and finance processes across ten systems were automated, reducing at least one task that took 12 days to complete to just six hours. The bots are now saving 3,900 human hours annually, an 85% reduction in time spent on manual tasks. With automation, there has also been a significant reduction in “exceptions” requiring intervention. And the company achieved these efficiencies without increasing headcount.

These metrics tell a story about people as well. With 1,100 human hours eliminated from peak processing periods and a measurable reduction in manual task time overall, the bots have supported better work/life balance for corporate tax and finance professionals. They now do less overtime, and are free to focus on more valuable work. The Vice President - Corporate Tax now oversees the RPA CoE and automation across the finance function. The company continues to roll out additional bots, as part of its evolving intelligent automation ecosystem.

To learn about PwC's automation perspective and discover how to reinvent your business, visit  pwc.com/us/automation .

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Boston scientific case study, graph data science streamlines complex medical supply chain analysis, the challenge.

Boston Scientific is highly vertically integrated in the development, design, manufacturing and sales of its medical products. This means that the company manufactures its complex devices, starting with raw materials such as resin and metal. Starting with raw materials requires a significant amount of batch processing in addition to discrete manufacturing of finished products.

With its complex manufacturing supply chains, Boston Scientific has numerous engineering teams aligned based on the process technology they’re using.

Many devices use multiple technologies, so multiple teams are involved. With multiple teams, often in different countries, working on the same problems in parallel, engineers resort to analyzing their data in spreadsheets.

Decentralized ad-hoc analytics led to inconsistencies and, most importantly, an inability to find root causes of defects.

Boston Scientific needed a far more effective method for analyzing, coordinating and improving their manufacturing processes across all its locations.

The Solution

Eric Wespi, Data Scientist at Boston Scientific, and his team understood the complexity of their business problem and their inability to address it using traditional tools. Wespi attended GraphConnect, where he met Eric Spiegelberg, a Senior Consultant at GraphAware, and decided to work with him on Boston Scientific’s supply chain problems.

Boston Scientific moved from considering graphs to vetting the technology. “This is where the quantum leap happens, where an organization goes from merely being a passive observer of the graph community to being an active participant,” said GraphAware’s Eric Spiegelberg. “It is typically embodied by an organization getting their actual data into Neo4j, which is a critical step because it forces the organization to evaluate the design decisions and build out their model.”

The heart of Boston Scientific’s graph data model consists of three nodes representing a finished product, a part and a failure, with relationships that trace failures to parts and connect those to finished products. This simple model effectively represents a complex medical device composed of dozens of parts, manufactured from raw materials.

The data model is simple, but Boston Scientific’s graph is massive. Using Neo4j graph algorithms from the Graph Data Science Library, the Boston Scientific team analyzes its graph and computes scores that rank nodes based on their proximity to failures, enriching its models with insights derived from the graph.

“We’re using Neo4j not as just a data store, but as a place to analyze data and store those new characteristics of the data back in the graph and then extract it for traditional analysis,” said Wespi.

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Wellbeing success - The Boston Scientific case study

Keeping your company well with ibec’s keepwell™ mark - the boston scientific case study in wellbeing success..

In 2018, Boston Scientific (a MedTech company with 6,000 employees in Ireland) began their journey to accreditation with us, working together to achieve an open, happy, and inclusive workplace.  The journey begins When you sign-up to the KeepWell™ Programme, the first step of assessment allows you to appraise and gain validation for the programmes you have in place.  From here, the KeepWell™ team worked with Boston Scientific to embed the KeepWell™ framework and standards with recommendations tailored to their company’s needs.

“ Our strategy is based around the KeepWell™ framework because we wanted to deliver programmes from a holistic approach, as advised by an accredited body .”

Framework benefits include: Encompasses an organisation-wide approach Offers benchmarking Delivers gap analysis Provides expert support Opens access to a like-minded business community Assists with management buy-in Ensures recognition, from a reputed source, for best-in-class wellbeing standards. Investing long-term Boston Scientific invested in a long-term commitment. But one that gave clear, tangible, and efficient results. 

“ Engagement with the KeepWell™ process gives a focus to delivering on Wellbeing Programmes and timelines. ”

2018 – Boston Scientific Galway signs up     2019 – Boston Scientific Galway accredits         2021 – Boston Scientific Cork signs up             2022 – Boston Scientific Galway reaccredits + Boston Scientific Cork accredits.

4 strategic steps With 6,000 employees, 3 national sites and many diverse departments, Boston Scientific’s wellbeing journey involved 4 core, strategic steps. 1.    Commit  In 2018, Boston Scientific established clear and committed goals, backed by leadership investment and support across the organisation to deliver on the agreed goals. -    Provide the highest standard of wellbeing, health and safety for all their employees -    Empower individuals to maintain their own wellbeing -    Prioritise a caring, healthy, and inclusive workplace at every site -    Promote open communication and reduce mental health stigma 2.    Resource Boston Scientific aligned internally, bringing teams together to deliver the strategy. The KeepWell™ Team provided expert advice and support in setting-up company-wide resources and networks.

“ Ibec’s KeepWell™ Mark Framework ensured that everyone, from the production line to management, had a voice and could get involved .”

A Campus Wellbeing Steering Committee was created to achieve The KeepWell™ Mark, support mental health initiatives and improve overall staff wellbeing. Importantly, the steering committee included a cross section of representatives from across the business Wellbeing Representatives were appointed across the production units. This provided a two-way communication path, ensuring that all the Wellbeing Initiative Resources and Wellbeing Communications were made accessible to everyone in every department, on every shift.

3.    Listen For Boston Scientific, listening to staff was one of the key steps towards understanding and where to improve systems. To win hearts and minds, to make sure every person is heard, and to bring everyone on the wellbeing journey, Boston Scientific conducts an annual survey.

“ We strive for continuous improvement and while we had some validation from our internal surveys, in terms of programmes which enhanced employee wellbeing, it is great to have that validated from a recognised accredited national standard. ”

4.    Communicate Once people could see the benefits of implementing the KeepWell Mark strategies, they actively got involved to deliver it at every level.

“ We used multiple channels to communicate with employees across the campus - from Wellbeing Boards, Campus Manager meetings, and e-mails, to leaflets and screen displays in the canteen. ”

To improve communications, Boston Scientific put in place a core Wellbeing Team plus an extended team of Wellbeing Champions across the production units.

“ Ensure all employees understand why you want to do this. The award is great recognition, but it’s not the main reason why you would embark on this journey. Once people understand the benefits of having a strategy that focuses on delivering the 8 core elements of the KeepWell™ Mark, you will gain internal momentum from employees who will deliver on the strategy .”

Top marks of success

“ Since engaging in the KeepWell™ process, general Wellbeing has been raised. This has resulted in openness around people discussing their issues .”

Through accreditation and continuous improvement, Boston Scientific now has: A network of mental health champions Enhanced culture of open communications Employee trust through commitment of resources to wellbeing Training and resources in place Independent validation of internal programmes A collaborative approach to wellbeing across all sites and departments

“ We proudly display our KeepWell™ Mark accreditation on our Wellbeing Board. ”   About KeepWell Ibec’s KeepWell™ Mark programme helps companies take a strategic approach to wellbeing for improved business performance. We do this through our wellbeing accreditation; The KeepWell™ Mark, and via the KeepWell™ Community programme which offers training on building effective wellbeing strategies, along with clinics, webinars and networking events. Discover your company’s existing strengths with this quick and easy, online mini assessment  or to find out more call a member of the team on 0818 546 546

Sophie Moran

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Boston Scientific's Upside With Cardiology Devices Drives Momentum

Mizuho Securities raised the price target for  Boston Scientific Corporation  (NYSE:BSX), saying the cardiology segment is poised to deliver double-digit growth.

Citing the virtual NDR group meeting, Mizuho Securities Managing Director Anthony Petrone said high-level feedback suggests that the cardiology segment is poised to maintain a “healthy” double-digit top-line growth profile for the foreseeable future supported by rapid Farapulse adoption, Watchman FLX upside from combo pulsed field ablation concomitant surgery with left atrial appendage closure (PFA and LAAC) surgery, and core CRM renaissance supported by Emblem S-ICD adoption.

Related:  Boston Scientific Lifts 2024 Profit Forecast On Strong Growth From Cardiovascular Devices, Stock Soars.

Mizuho wrote, “Feedback supports our view that U.S. Farapulse contribution can approach our $400 million bull case scenario this year while combo PFA + LAAC surgery can drive Watchman FLX growth back over +20% heading into next year.”

With a Buy rating, Mizuho increased the price target from $85 to $90, and cited that the scenarios from PFA and LAAC combo surgery volumes support a higher $115 bull case price target.

The analyst said the Farapulse launch in the U.S. mirrored its European rollout. Faster ablation times increased capacity by about 36%, leading to more scheduled cases. 

The company anticipates that results from their persistent atrial fibrillation (AF) trials will boost awareness and treatment, further expanding the PFA market.

Boston Scientific anticipates substantial growth for its blockbuster product, already generating over $1 billion, with a near-term growth projection of +20% due to deeper market penetration. 

The Option trial is evaluating the Watchman device as an alternative to anticoagulation following ablation procedures. Data are expected in late 2024 or early 2025, leading to label expansion and increased use. 

The Champion trial results, expected in the first half of 2026, could further extend the product’s use to AF patients before ablation. Concerns about competition from new Factor 11 inhibitor anticoagulants seem overstated due to their uncertain efficacy, high cost and need for regular injections.

Mizuho noted, “All in, the momentum in Watchman is likely to continue for years driven by increased penetration through label expansions combined with updated guidelines and reimbursement tailwinds.”

BSX Price Action:  Boston Scientific Corporation shares are up 0.94% at $74.18 at last check Wednesday.

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Assessing the comparative safety of novel pulmonary embolism treatments

Each year, approximately 900,000 patients in the US are affected by a pulmonary embolism, a blood clot causing a blockage in one or more pulmonary arteries in the lungs. Despite the availability of new therapies, there are no randomized prospective studies comparing them, and clinical guidelines have not been updated to reflect the real-world safety of these options in a modern setting.   To close these knowledge gaps, Boston Scientific turned to a team of independent researchers to conduct a comparative safety analysis using Truveta Data.   Download the case study for insight into: 

• Why traditional RWD sources fall short in enabling timely research on specific medical devices 
• The precise data types required to complete the analysis 
• The study methodology, key outcome measures, results, and impact  

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Download Fusion's guide "Evaluating Business Continuity Management Software: A Buyer's Guide for Practitioners"

A Cross-Functional Approach to Resilience

Boston Scientific Corporation (BSC) is committed to “transforming lives through innovative medical solutions that improve the health of patients around the world.” The company manufactures medical devices used across multiple specialties, including radiology, cardiology, vascular surgery, endoscopy, oncology, urology, and gynecology. The company was founded in 1979, went public in 1982, and has grown to global prominence organically and through a series of strategic mergers and acquisitions.

Here, Boston Scientific Corporation tells their story of how they utilize the Fusion Framework® System™ to score and assess all of their supplier and vendor risks.

Today, BSC is a Fortune 500 company with $11.9 billion in sales, seven operating divisions, and 17,000-plus products that serve about 30 million patients per year. It invests about $1 billion annually in research and development. In 2021, the company rolled out 90 new products and secured 18,000 patents globally. BSC has 41,000 employees (50,000 including contractors) at 164 sites, including 16 principal manufacturing facilities worldwide. It has commercial representation in 115 countries, and 42 percent of its net sales occurred outside of the U.S. in 2021.

A New Urgency Around Supply Chain Risk

Jennifer Park joined Boston Scientific Corporation as Manager of Business Continuity, following roles in business continuity at Hanover Insurance and the Gemological Institute of America. BSC had recently decided to implement the Fusion Framework® System™, a platform which aligns a company’s strategic objectives to key risk management techniques through flexible and agile tools. Park was easily able to configure the Fusion Framework System in-house to meet BSC’s specific needs. Like many large growth-focused companies, BSC’s previous business continuity efforts were largely decentralized and archived in documents and spreadsheets.

The BSC business continuity plan (BCP) is designed to ensure that operations will continue to function with little or no disruption and at a high quality of service delivery regardless of the scope of the situation or event. The COVID-19 pandemic is an example of such an event.

Like most manufacturers, BSC experienced supply chain challenges as the pandemic persisted through 2020 and 2021. Understanding supply chains and loss of suppliers took on new urgency, as well as managing risks from suppliers who were coping with the pandemic. Within this new age of disruption, the Fusion Framework System is becoming the central repository for the company to score and assess all supplier and vendor risks.

Working with technology teams at BSC, Park used the Fusion Framework’s data libraries to build out applications that are needed on BSC’s many manufacturing lines. The teams used data from all applications across the company – including finance, payroll, taxes, and more – in order to understand the resilience and disaster recovery challenges that the company could face in the world changed by the pandemic.

Interviewing for Success

Park uses an “interview style” when she meets with department heads to further build out Boston Scientific Corporation’s BCPs. She helps them determine which processes are critical to ongoing operations and which processes could be put on hold in an emergency. Different departments have varying views on risk, but the Fusion Framework provides a view that helps create an understanding of application interdependencies. Top management and department heads can see the overall impact of the loss of specific processes or applications on the entire company and use that to set priority levels according to risks of business disruptions.

One single application outage may cause a business disruption. “Wait for application” as a recovery strategy may cause variable levels of operational impact. But waiting might bring a line down, a site down, or an entire manufacturing division down. If department heads and manufacturing line managers can see the overall risk to the company, they can get ahead of a situation and share important information or make resiliency decisions to avert outages.

BCP as a Change Agent

Park says: “Because we make medical devices, it’s harder to source from a wide number of vendors. It’s not like with auto parts.”

All of BSC’s goods and materials need FDA approval – thus, replacing disrupted suppliers and vendors can take a significant amount of time. But the Fusion Framework System gives BSC a view of its vendors and suppliers and is helping the company identify potential risks and mitigate them early. The BCP process drives conversations around developing workarounds or improving other dependencies.

According to Park, “Fusion’s unique look at our process-application dependencies highlights known and unknown risks around specific applications and operations and brings to light critical business dependencies upon non-class A apps. Fusion allows us to create true end-to-end mapping of individual product families and identify risks in key categories such as tech, suppliers, equipment, and more. This is helping us take a cross-functional approach and bring silos of data together in one place to better understand our current gaps and risks and develop mitigation strategies through reporting, dashboards, and workflows.”

More Than Just “Checking the Boxes”

Park had worked with the Fusion Framework System prior to BSC and shared the competitive advantage that experience with the Framework can provide.  “Fusion helps me frame and think about business continuity as providing value to a company, not just checking the business continuity box. Fusion gives us a chance to develop meaningful data for our company as we continue building a culture of resilience.”

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Boston Scientific succeeds in pivotal trial for leadless pacemaker

Joe Raedle/Getty Images News

Boston Scientific ( NYSE: BSX ) announced Saturday that its pivotal clinical trial for the modular cardiac rhythm management (CRM) system, which comprises its EMPOWER leadless pacemaker, met all safety and effectiveness goals.

Citing six-month results from its MODULAR ATP study, BSX said that communication between the EMPOWER LP and mCRM's second component, the EMBLEM subcutaneous implantable defibrillator (S-ICD) System, was highly successful.

The announcement came after the company published the data readout in a medical journal and presented it at Heart Rhythm 2024, the annual meeting of the Heart Rhythm Society. The Marlborough, MA-based MedTech expects FDA approval for the mCRM System in 2025.

Instead of subjecting patients to the risks of more invasive approaches, "these data indicate physicians may have the opportunity to tailor therapy to the patient's individual needs and health," Boston Scientific's ( BSX ) chief global medical officer Kenneth Stein remarked.

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• Boston Scientific Non-GAAP EPS of $0.56 beats by $0.05, revenue of $3.86B beats by $180M

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