Merit Medical to Exhibit at Virtual ASBrS 2021: Products and Symposia You Won’t Want to Miss

ASBrS Virtual 2021Merit Medical is proud to support the American Society of Breast Surgeons (ASBrS) 22nd Annual Meeting on April 29–May 2, 2021.

We look forward to connecting with you virtually and encourage you to visit the Merit virtual booth to learn of our latest product platform enhancements and clinical updates.

We are also sponsoring a very compelling industry symposium and two learning sessions, all featuring key opinion leaders and experts in breast cancer care. Mark your calendars to include these products and symposia you won’t want to miss:

PRODUCTS

As a provider of world-class solutions for the diagnosis, localization, and treatment of cancer, Merit Oncology consistently invests in improving technologies and innovating new platforms to meet physicians’ needs.

SCOUT® RADAR LOCALIZATION

SCOUT Radar Localization - Preferred Solution to Treat More Patients - Merit OncologyThe easy-to-use SCOUT Radar Breast Localization System is intended for both breast surgical localization, before or after neoadjuvant chemotherapy, and to mark a biopsy site. Its reflector has a clinically insignificant MRI artifact, so there is no restriction on the imaging modalities that can be used effectively throughout treatment. SCOUT provides accurate detection and precise localization and has been shown to improve workflow, significantly reducing OR delays.

Explore clinical data and hear why physicians choose SCOUT.


SAVI® BRACHY

SAVI Brachy - APBI BrachytherapySAVI Brachy offers a strut-based approach to tissue-sparing dosimetry and is designed to maximize ease of use during placement while providing unparalleled dose customization. Three-fraction treatment protocol with SAVI allows for effective APBI treatment to be completed in as little as 2 days,1 significantly reducing the treatment burden for patients.

Explore clinical data and COVID-specific materials.


ACHIEVE® PROGRAMMABLE AUTOMATIC BIOPSY SYSTEM

Achieve Automatic Biopsy DeviceDesigned for calcified or fibrous lesions, the lightweight, automatic Achieve device is spring-loaded for fast, accurate penetration. Its delayed-firing option allows for visualization of needle placement within a lesion before capturing sample tissue. The Achieve gives precise control and quality sampling capability needed, is built to minimize damage to surrounding tissue, and can conveniently be operated with one hand—making it ideal for ultrasound-guided biopsy.

Explore the Achieve device.

SYMPOSIA

ASBrS Breakfast Symposium

The Preferred Localization Solution to Treat More Patients: SCOUT

Friday, April 30, 2021
9:00 am – 10:00 am EDT

Description:

SCOUT Radar Localization exclusively spans the care continuum from time of biopsy placement and targeted axillary dissection to excellent surgical outcomes. Discover the state-of-the art localization techniques practiced by key opinion leaders from Cleveland Clinic, Columbia University, University of Colorado, Intermountain Healthcare, and the Advocate System.

Learning Sessions

The Pathway to Market Leadership and the Future of Radar Localization

Includes physician education recording with Michelle Carpenter, MD

Friday, April 30, 2021
2:45 pm – 3:15 pm EDT

Description:
At the time of the 2021 ASBrS meeting, SCOUT will have achieved an important milestone—200K procedures, far exceeding any other wire-free technology.

Join David Gilstrap, Director of Global Product Management at Merit, to learn more about what differentiates radar localization and what is on the horizon for platform enhancements. His presentation will include a physician education recording with Michele Carpenter, MD.

Start-to-Finish APBI in 2 Days: Three-Fraction Treatment with SAVI

Saturday, May 1, 2021
9:15 am – 9:4 5am EDT

Description:
Interested in learning about three-fraction APBI with SAVI? Listen to UC San Diego’s Cate Yashar, MD, and Dan Scanderbeg, PhD, as they discuss outcomes of the TRIUMPH-T Trial, provide an assessment on patient satisfaction, and discuss adopting a three-fraction TRIUMPH-T protocol in your practice.


At Merit, our goal is to lessen the burden cancer places on patients and their loved ones by offering products and services that make this possible. We look forward to seeing you at virtual ASBrS 2021!

Learn more about ASBrS 2021.

*Before using any of the Merit products mentioned above, refer to Instructions for Use for indications, contraindications, warnings, precautions, and directions for use.


REFERENCES

  1. Khan AJ et al. 2019. “Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial.” Int J Radiat Oncol Biol Phys 104, no. 1:67– PMID: 30611839.
Merit Medical - ISO Certifications for Environmental and Employee Sustainability Efforts

Merit Medical ISO Certified for Environmental Sustainability and Employee Safety

Merit Medical - ISO Certifications for Environmental and Employee Sustainability EffortsAt Merit Medical, our mission as a global healthcare company is to improve the lives of people, families, and communities around the world. A significant part of caring for people is also ensuring our practices as a company protect the safety of our employees and the well-being of the environment.

To help guide us, our facilities worldwide use a set of international standards created by ISO (International Organization of Standardization)—an independent, non-governmental global group that develops guidelines for companies like Merit to use to help ensure quality, efficiency, and safety of its products, services, and systems.

There are many different ISO certifications, each with separate standards and criteria to follow. No matter the focus, ISO certification means that a system, protocol, service, or procedure has met all the requirements for that specific standardization.

The following is a breakdown of the ISO certifications within our sustainability program that our facilities have received as well as our goals for 2021–2022:

ISO 14001: ENVIRONMENTAL MANAGEMENT SYSTEMS

ISO 14001 is the international standard for certifying an environmental management system (EMS) to enhance environmental performance. Merit’s EMS has several components, for example the practices, policies, goals, legal requirements, and progress monitoring that enable us to reduce our environmental impact and increase operating efficiency. ISO 14001 standards have helped guide our company in developing the EMS for each of our manufacturing facilities.

Merit Facilities with ISO 14001 Certification

Merit Galway

Merit Paris

Merit Salt Lake

Merit Singapore

ISO Goal

Environmental Commitment All Merit manufacturing facilities will be ISO 14001 certified by the end of 2021.

Currently, the following Merit facilities are pursuing certification:

Merit Houston

Merit Richmond

Merit Tijuana


ISO 45001: Occupational Health and Safety Management Systems

ISO 45001 guides businesses in standardizing their Occupational Health & Safety (OH&S) management system to continuously seek reduction in occupational injuries and/or diseases including promoting and protecting physical and mental health. Merit’s goal to obtain certification of its OH&S system is the next step in maintaining and improving our top priority to provide a healthy and safe workplace by controlling factors that could lead to injury or illness.

ISO Goal

Compassion & Employee Safety All Merit manufacturing facilities will be ISO 45001 certified by the end of 2022.

At this time, the following Merit facilities are pursuing certification:

Merit Galway

Merit Houston

Merit Richmond

Merit Salt Lake

Merit Singapore

Merit Tijuana


ISO 50001: Energy Management Systems

ISO 50001 standards provide businesses with guidance for improving energy conservation by developing an energy management system (EnMS). Much like the aforementioned EMS, an EnMS incorporates energy management into business practices and policies, enabling companies to better manage their energy use, conserve resources, and improve energy performance.

Merit Facilities with ISO 50001 Certification

Merit Galway

ISO Goal

Energy EfficiencyAll Merit manufacturing facilities will have or be pursuing ISO 50001 certification by the end of 2022. At this time, the following Merit facilities are already pursuing certification:

Merit Salt Lake

Merit Singapore


We understand and recognize our responsibility as a good corporate citizen. By pursuing continuous improvement through ISO standardization, we reaffirm our commitment to building a sustainable world for our business, our future, and our communities.

We wish everyone a Happy Earth Day 2021!

Addressing Complications of Esophageal Stenting with the EndoMAXX® Stent

EndoMAXX Esophageal StentFully covered self-expanding metal stents are commonly used for palliating malignant strictures. Merit Medical’s Endotek® division developed the EndoMAXX®, an esophageal stent indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and for occlusion of esophageal fistulae.

There are numerous treatment options available to help in the palliation of a malignant esophageal obstruction, such as photodynamic therapy, thermal ablative techniques, surgical resection or bypass, and chemotherapy/radiotherapy. However, endoscopic stenting offers significant advantages over these other therapies, as stents are generally easy and quick to place. They are safe, have a good complication profile, and are well-tolerated with a low incidence of significant pain.1,2

Despite having a good complication profile, two common complications of esophageal stenting exist: chest pain and stent migration. The EndoMAXX is designed to address each.

Chest pain due to esophageal stent placement has incidence rates ranging from 12%3 to as high as 37%.4 This pain is typically due to the expansion force, or outward pressure, an esophageal stent exerts on esophageal tissue, a tumor, or a stricture when implanted. It is believed that this force directly corresponds to the discomfort the patient feels while the stent is in place. Clinical guidance also suggests this force may contribute to perforation, a life-threatening additional complication that can occur with an esophageal stent.

The expansion force of the EndoMAXX is 2.4 N, compared to 5.4 N of the market-leading esophageal stent in the US.5 In addition, the EndoMAXX stent is designed with 2.5 cm of flare at each end of the stent. This feature helps anchor the stent within the esophageal lumen. Soft flared ends and a firm mid-body help to dilate an obstruction while protecting healthy esophageal mucosa.

EndoMAXX - Example of Advanced Patient-Focused Design

Beyond having a lower radial force, the laser-cut design of the EndoMAXX has virtually no foreshortening or elongation of the stent during deployment, allowing for accurate sizing to the patient’s anatomy. A recent study published by Essrani et al. in Cureus Journal of Medical Science confirmed that “[t]he most common complication  . . . encountered was chest pain, which was transient and mostly resolved without any intervention.”2

In addition, a study by Dua et al. published in Gastrointestinal Endoscopy showed that “[c]hest pain was reported in 11% of patients, and in two-thirds of these cases chest pain developed several weeks after stent placement while the patients were receiving radiotherapy.” The authors concluded that “[t]he relatively low incidence of chest pain in this series could be related to the use of smallest-diameter (19 mm) stents in all patients with strictures.”1

AliMAXX-ES Fully Covered Esophageal StentTo meet the clinical need for a large-diameter stent, the EndoMAXX is available in 19-mm and 23-mm diameters. For clinical scenarios that require either a small diameter stent and/or when chest pain is a concern, Merit Endotek also offers the ALIMAXX-ES Esophageal Stent that is available in smaller diameters ranging from 12 mm to 22 mm. ALIMAXX-ES stents are designed to have a lower expansion force of 1.6 N, potentially reducing pain experienced by patients.

Migration is also a common complication of esophageal stent placement. Research shows migration rates for self-expanding metal stents range from 23 % to 31 % in malignant strictures. 6-8 In an effort to reduce migration, the EndoMAXX stent is designed with proprietary anti-migration struts that provide increased mucosal wall contact and friction.

EndoMAXX - Designed with Anti-Migration StrutsAccording to the aforementioned study by Dua et al., “stent migration occurred in 4 of 35 patients (11%)” and “all stent migrations were distal.”1 It is to be noted that not all migration is bad. When a patient’s tumor shrinks from cancer treatment, the stent has nothing to compress against and can migrate distally.

The EndoMAXX is designed with both proximal and distal metal sutures to provide a means for repositioning of the stent post placement and removal if necessary. This can be accomplished by using rat-tooth forceps and grasping the gold metal bead in the suture loop at the proximal end of the stent. Then carefully, using a purse-string effect, the proximal end of the stent is released from contact with the esophageal wall and traction is applied as it is removed.

No surgery is free of complications, but choosing products designed to decrease their incidence may result in better patient outcomes. Merit’s esophageal stents have a number of key features that address common concerns associated with esophageal stent placement, all while maintaining luminal patency.

For more information regarding esophageal stenting solutions, visit our GI Stricture Management page, the EndoMAXX product page, or connect with our Customer Support Center.


References

  1. Dua K et al. 2014. “Efficacy and Safety of a New Fully Covered Self-Expandable Non-Foreshortening Metal Esophageal Stent.” Gastrointestinal Endoscopy 80, no. 4 (Oct): 577–585. PMID: 24685007.
  2. Essrani R et al. 2020. “Complications Related to Esophageal Stent (Boston Scientific Wallflex vs. Merit Medical Endotek) Use in Benign and Malignant Conditions.” Cureus Journal of Medical Science12, no. 3 (Mar 23): e7380. PMID: 32328390.
  3. Hindy P et al. 2012. “A Comprehensive Review of Esophageal Stents.” Gastroenterol Hepatol (NY) 8, no. 8 (Aug): 526–534. PMID 23293566.
  4. van Boeckel P et al. 2010. “A New Partially Covered Metal Stent for Palliation of Malignant Dysphagia: A Prospective Follow-up Study.” Gastrointest Endosc 72, no. 6: 1269–1273. PMID: 20951988.
  5. Data on File.
  6. Siddiqui A et al. 2012. “Placement of Fully Covered Self-Expandable Metal Stents in Patients with Locally Advanced Esophageal Cancer Before Neoadjuvant Therapy.” Gastrointestinal Endosc 76, no. 1 (Jul): 44–51. PMID: 22726465.
  7. Martinez J et al. 2011. “Esophageal Stenting in the Setting of Malignancy.” ISRN Gastroenterology 2011: 719575. PMID: 21991527.
  8. Shenfine J et al. 2005. “A Pragmatic Randomized Controlled Trial of the Cost-Effectiveness of Palliative Therapies for Patients with Inoperable Esophageal Cancer.” Health Teach Assess 9, no. 5 (Feb): 1–121. PMID: 15717937.
Understanding Esophageal Cancer

Helping You Understand Esophageal Cancer