Merit Medical Receives FDA Breakthrough Device Designation for the New SCOUT® MD™ Surgical Guidance System

Rhea-AI Summary

Merit Medical Systems has received FDA Breakthrough Device Designation for its SCOUT MD Surgical Guidance System, enhancing surgical precision for breast and soft tissue cancer treatments. This innovative system allows the implantation of up to four unique reflector configurations, improving tumor localization and minimizing damage to healthy tissue, thereby reducing the need for repeat surgeries. With breast cancer being the most common cancer globally, representing 12.5% of new cases, the SCOUT MD aims to optimize surgical outcomes and patient care. Merit commits to advancing oncology technologies, enhancing patient experiences in cancer treatment.

Positive

• FDA Breakthrough Device Designation for SCOUT MD enhances product credibility.
• Improves surgical precision, potentially decreasing the rate of repeat surgeries.
• Expands Merit Medical's portfolio in oncology, addressing a significant market need.

Negative

• None.

Next-generation system helps improve surgical precision to enhance patient care in breast and other soft tissue cancer treatment

SOUTH JORDAN, Utah, Feb. 16, 2023 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today the FDA has granted Breakthrough Device Designation for the SCOUT MD Surgical Guidance System.

The SCOUT MD is the latest step in Merit’s ongoing commitment and leadership in advancing oncology care. SCOUT MD expands Merit’s portfolio of products to optimize oncology for breast and other soft tissue cancers, which includes the SCOUT® Radar Localization system with new SCOUT® Mini Reflector and SCOUT Bx™ Delivery System, and the SAVI® Brachy System.

A first of its kind, the SCOUT MD localization system supports implantation of up to four unique reflector configurations. When implanted within abnormal breast or other soft tissue, the reflectors enable surgeons to pinpoint tumor location in multiple dimensions for more precise excision, minimizing trauma to healthy tissue and helping to reduce the likelihood of re-excision and the emotional and physical pain associated with a second surgery.

Breast cancer is the most common cancer worldwide, representing 12.5% of all new annual cancer cases.¹ Lumpectomy (a type of breast conserving surgery) is often performed as treatment. However, an estimated 20% to 30% of women who undergo lumpectomy will need a repeat surgery.² Localization procedures help surgeons precisely target breast cancer, which may result in more successful surgeries and improved patient outcomes.

“This designation recognizes the significant contribution we believe SCOUT MD can make in oncology treatment,” said Fred P. Lampropoulos, Merit Medical’s Chairman and CEO. “A diagnosis of cancer is devastating to patients and their loved ones. Merit is committed to delivering new technologies to improve outcomes and enhance the patient experience in cancer care. SCOUT MD is designed to help increase the precision with which surgeons can operate, supporting tissue-conserving treatment and reduced reintervention. We look forward to working with the FDA to make this important technology available to patients.”

FDA Breakthrough Device Designation is intended to help patients receive timely access to technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA provides priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.

ABOUT MERIT MEDICAL 

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 600 individuals. Merit employs approximately 6,800 people worldwide. 

TRADEMARKS 
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc. and its subsidiaries in the United States and other jurisdictions. 

CONTACTS 
PR/Media Inquiries 
Sarah Comstock
Merit Medical 
+1-801-432-2864 | sarah.comstock@merit.com

Investor Inquiries 
Mike Piccinino, CFA, IRC 
Westwicke - ICR 
+1-443-213-0509 | mike.piccinino@westwicke.com

References 

1. BreastCancer.org. 2023. “Breast Cancer Facts and Statistics.” Last modified January 18, 2023. https://www.breastcancer.org/facts-statistics
   
   
2. Havel, Liska et al. 2019. “Impact of the SSO-ASTRO Margin Guideline on Rates of Re-excision After Lumpectomy for Breast Cancer: a Meta-analysis.” Annals of Surgical Oncology 26 (5): 1238 ̶ 1244.

FAQ

What is the SCOUT MD Surgical Guidance System from Merit Medical?

The SCOUT MD is a next-generation surgical guidance system designed to improve precision in the excision of tumors in breast and soft tissue cancers.

What does FDA Breakthrough Device Designation mean for Merit Medical?

It allows for priority review and support from the FDA in developing the SCOUT MD, potentially expediting its availability to patients.

How does the SCOUT MD improve surgical outcomes?

By allowing surgeons to implant reflectors that improve tumor localization, thus minimizing trauma to surrounding healthy tissue and reducing the likelihood of repeat surgeries.

What percentage of women need repeat surgery after lumpectomy?

An estimated 20% to 30% of women who undergo lumpectomy may require a repeat surgery.

What is the significance of breast cancer statistics mentioned in the press release?

Breast cancer accounts for 12.5% of all new annual cancer cases, underscoring the demand for effective treatment solutions like SCOUT MD.