Merit Medical Systems initiates a study to evaluate the Bloom Micro Occluder System for treating patent ductus arteriosus in premature infants.
Quiver AI Summary
Merit Medical Systems, Inc. has announced the enrollment of the first patient in its PREEMIE study, which is a multicenter, prospective trial evaluating the Bloom Micro Occluder System for treating patent ductus arteriosus (PDA) in premature infants. PDA is a heart condition where a blood vessel fails to close after birth, affecting blood flow and potentially harming low-birth-weight infants. The Bloom Micro Occluder offers a minimally invasive treatment alternative, using a flexible delivery system to deploy a nitinol device that blocks blood flow through the PDA. The study aims to enroll at least 55 infants weighing between 600 and 2,500 grams and will assess the device's safety and efficacy over six months. Key medical professionals involved in the study highlight its potential to revolutionize care for fragile patients, as there are currently no approved devices for such small infants. Merit Medical hopes this study will address significant unmet needs in treating this vulnerable population. The Bloom Micro Occluder system is not yet approved for clinical use.
Potential Positives
- Enrollment of the first patient in a multicenter study signals progress in developing a novel treatment for patent ductus arteriosus (PDA) in premature infants, potentially addressing a significant unmet medical need.
- The Bloom Micro Occluder System is designed to be minimally invasive, which may lead to safer and more effective treatment options compared to traditional surgical methods for fragile patients.
- The PREEMIE study has the potential to change pediatric interventional cardiology by providing new options for treating high-risk premature infants with hemodynamically significant PDAs.
- The study's results could pave the way for regulatory approval of a much-needed device for PDA treatment in this vulnerable population, enhancing Merit's position in the healthcare technology market.
Potential Negatives
- The Bloom Micro Occluder System is not currently approved to treat PDA, indicating that the company is still in the experimental phase and has not yet achieved regulatory approval for its product.
- The study involves a vulnerable patient population (premature infants), which may raise ethical concerns and scrutiny regarding patient safety and treatment efficacy.
- There are limited options for treating PDA, suggesting potential challenges in market adoption and the need for further validation of the product's effectiveness compared to existing solutions.
FAQ
What is the Bloom Micro Occluder System?
The Bloom Micro Occluder System is a minimally invasive device designed to treat patent ductus arteriosus (PDA) in premature infants.
What condition does the PREEMIE study address?
The PREEMIE study addresses patent ductus arteriosus (PDA), a congenital heart condition common in premature, low-birth-weight infants.
How many infants will be enrolled in the PREEMIE study?
At least 55 premature infants with hemodynamically significant PDA will be enrolled in the PREEMIE study across ten U.S. sites.
What are the weight requirements for participants in the PREEMIE study?
Participants must weigh between 600 grams and 2,500 grams, which includes extremely low and low birth weight categories.
Is the Bloom Micro Occluder System currently approved for use?
No, the Bloom Micro Occluder System is not currently approved for treating PDA in infants.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$MMSI Insider Trading Activity
$MMSI insiders have traded $MMSI stock on the open market 15 times in the past 6 months. Of those trades, 0 have been purchases and 15 have been sales.
Here’s a breakdown of recent trading of $MMSI stock by insiders over the last 6 months:
- BRIAN G. LLOYD (CHIEF LEGAL OFFICER, SECRETARY) has made 0 purchases and 2 sales selling 55,000 shares for an estimated $5,574,500.
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$MMSI Hedge Fund Activity
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Here are some of the largest recent moves:
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Full Release
SOUTH JORDAN, Utah, March 10, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced enrollment of the first patient in its multicenter, prospective study of the Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in premature infants (PREEMIE study).
PDA is a congenital heart condition that occurs when the ductus arteriosus, a blood vessel connecting the aorta and pulmonary artery, does not close following birth. The condition is common in premature, low-birth-weight infants. A PDA affects the way blood flows through a baby’s lungs. A hemodynamically significant or large PDA (hsPDA) can negatively affect a baby’s health and require treatment to close the opening. Today, minimally invasive treatment options offer alternatives to surgery or delayed treatment after watchful waiting.
Merit’s Bloom Micro Occluder System was designed to be a minimally invasive option for treating hemodynamically significant PDAs. Bloom uses a flexible delivery system that is inserted through the blood vessels to deliver a small self-expanding nitinol device to the heart of the patient to block blood flow through the PDA. Bloom’s short flexible delivery system is designed for small patients and to streamline procedures by reducing procedural steps. The PREEMIE study has been developed to evaluate the safety and efficacy of the Bloom Micro Occluder System. Merit proposes to enroll at least 55 premature infants with hsPDA at up to ten U.S. study sites. To be eligible, patients must weigh between 600 g and 2,500 g, which are considered “extremely low birth weight” and “low birth weight,” respectively. Merit intends to evaluate safety and efficacy through six months as part of the premarket approval application.
“As there is currently no approved device for PDA in premature infants as small as 600 grams, we believe this study will provide critical information for treating this high-risk population,” said Howaida G. El-Said, MD, PhD, Director of the Cardiac Catheterization Laboratory at Rady Children’s Hospital in San Diego, CA, and National Principal Investigator of the PREEMIE study. “Bloom’s versatile and softer device design may enable safer and more effective care for these fragile patients.”
“Options for transcatheter device closure of PDA are limited,” said Thomas J. Forbes, MD, Chief of Pediatric Cardiac Services at Joe DiMaggio Children’s Hospital in Hollywood, FL, and one of the investigators in the PREEMIE study. “This study is a potential game changer for pediatric interventional cardiologists, allowing us the option to more reliably perform procedures at bedside.”
“At Merit, we strive to help our physician partners resolve unmet needs of their patients,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We look to the PREEMIE study to have a critical role in improving care for many vulnerable premature infants who would benefit from closure of their PDA using a transcatheter device.”
The PREEMIE study is an Investigational Device Exemption (IDE) study. The Bloom Micro Occluder System is not currently approved to treat PDA. For additional information on the PREEMIE study, including ongoing updates, please visit: https://clinicaltrials.gov/study/NCT06587282.
ABOUT MERIT
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,400 people worldwide.
TRADEMARKS
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors.
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
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