Merit Medical Receives FDA Clearance for SCOUT Bx™ Delivery System

Rhea-AI Summary

Merit Medical Systems has received FDA clearance for its new SCOUT Bx Delivery System, a wire-free breast localization solution that streamlines the biopsy process. This innovative technology allows for the placement of a tiny reflector during stereotactic or MRI-guided biopsies, eliminating the need for an additional office visit. Annually, over 300,000 women undergo breast cancer surgery, and the SCOUT Bx can enhance surgical precision. This system builds on Merit's established SCOUT technology, used in nearly 300,000 procedures globally, aiming to improve patient outcomes.

Positive

• FDA clearance for SCOUT Bx Delivery System enhances product portfolio.
• Streamlines biopsy process, reducing patient burden with no additional procedures.
• Compatible with widely-used biopsy devices, improving market penetration.
• SCOUT technology has been used in nearly 300,000 procedures, showcasing its acceptance.

Negative

• None.

New technology is designed to allow physicians to place SCOUT® reflector at time of biopsy for breast localization under stereotactic and MRI guidance

SOUTH JORDAN, Utah, April 11, 2022 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, has received FDA clearance for the SCOUT Bx™ Delivery System, the first wire-free breast localization solution that can be deployed at the time of stereotactic or MRI-guided biopsy.

Each year more than 300,000 women undergo surgery related to breast cancer. Radar localization procedures help physicians surgically remove abnormal tissue while minimizing trauma to surrounding healthy tissue. By implanting a tiny reflector, the size of a grain of rice, physicians can precisely target affected tissue, resulting in more successful surgeries and improved patient outcomes. Today, roughly 40 percent of breast biopsies are performed under stereotactic or MRI guidance, creating the need for an additional office visit for reflector placement prior to surgery. SCOUT Bx is compatible with the most commonly used stereotactic and MRI guided breast biopsy devices on the market, allowing the patient to avoid an additional procedure.

Brett T. Parkinson, MD, diagnostic radiologist at Intermountain Healthcare in Salt Lake City, UT and a consultant of Merit, has been a leader in developing protocols to place SCOUT reflectors at time of biopsy. “Patients appreciate that they do not have to return to the breast center for a second procedure at a stressful time in their treatment planning,” said Dr. Parkinson. “The SCOUT Bx system is designed to allow clinicians to offer this streamlined pathway to a broader group of patients. This benefits patients as well as the healthcare system." 

The SCOUT Bx system is the newest addition to the Merit Oncology Breast and Soft Tissue Localization portfolio. Merit Oncology offers a wide range of localization and brachytherapy technologies to meet diverse clinical needs. Merit recently launched the SCOUT Mini Reflector which is optimally sized for lymph node placement.

“The SCOUT System is the market leader in wire-free breast surgical localization. Merit is committed to maintaining this leadership through continuous innovation to advance and streamline treatment for cancer patients,” said Fred P. Lampropoulos, Merit Medical’s Chairman and CEO. “Placement at the time of biopsy lessens the burden on cancer patients and benefits healthcare providers. The SCOUT Bx system expands this important treatment option to more patients. Merit is proud to be the first to market with this solution.”

The SCOUT system has been utilized in nearly 300,000 breast localizations worldwide and has been referenced in more than 65 clinical publications. SCOUT is the only localization system cleared for long-term implant status for breast and soft tissue.

Learn more about the SCOUT Radar Localization system.

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 in excess of 500 individuals. Merit employs approximately 6,500 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

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

FAQ

What is the SCOUT Bx Delivery System by Merit Medical?

The SCOUT Bx Delivery System is a wire-free breast localization solution that allows for reflector placement during stereotactic or MRI-guided biopsies, streamlining the process for patients.

When did Merit Medical receive FDA clearance for SCOUT Bx?

Merit Medical received FDA clearance for the SCOUT Bx Delivery System on April 11, 2022.

How does SCOUT Bx benefit breast cancer patients?

SCOUT Bx reduces the need for an additional office visit for reflector placement, minimizing stress and improving surgical outcomes for breast cancer patients.

How many procedures have utilized the SCOUT system worldwide?

The SCOUT system has been utilized in nearly 300,000 breast localization procedures globally.

What is the significance of SCOUT Bx in biopsy procedures?

SCOUT Bx allows for precise targeting of affected tissue during biopsies, leading to more successful surgeries and better patient outcomes.