First Patient Enrolled in Merit Medical’s PREEMIE Study
Merit Medical Systems (NASDAQ: MMSI) has announced the enrollment of the first patient in its PREEMIE study, evaluating the Bloom Micro Occluder System for treating patent ductus arteriosus (PDA) in premature infants.
The multicenter, prospective study aims to enroll at least 55 premature infants weighing between 600g and 2,500g at up to ten U.S. sites. The study will evaluate the safety and efficacy of the device through six months as part of the premarket approval application.
The Bloom system is designed as a minimally invasive treatment option, using a flexible delivery system to insert a self-expanding nitinol device that blocks blood flow through the PDA. Currently, there is no approved device for PDA treatment in premature infants as small as 600 grams.
Merit Medical Systems (NASDAQ: MMSI) ha annunciato l'arruolamento del primo paziente nel suo studio PREEMIE, che valuta il Bloom Micro Occluder System per il trattamento del dotto arterioso persistente (PDA) nei neonati prematuri.
Lo studio multicentrico e prospettico mira ad arruolare almeno 55 neonati prematuri con un peso compreso tra 600g e 2.500g in fino a dieci centri negli Stati Uniti. Lo studio valuterà la sicurezza e l'efficacia del dispositivo per un periodo di sei mesi come parte della domanda di approvazione pre-commerciale.
Il sistema Bloom è progettato come un'opzione di trattamento minimamente invasiva, utilizzando un sistema di somministrazione flessibile per inserire un dispositivo in nitinol autoespandibile che blocca il flusso sanguigno attraverso il PDA. Attualmente, non esiste un dispositivo approvato per il trattamento del PDA nei neonati prematuri con un peso di soli 600 grammi.
Merit Medical Systems (NASDAQ: MMSI) ha anunciado el reclutamiento del primer paciente en su estudio PREEMIE, que evalúa el Bloom Micro Occluder System para tratar el conducto arterioso persistente (PDA) en bebés prematuros.
El estudio multicéntrico y prospectivo tiene como objetivo reclutar al menos 55 bebés prematuros que pesen entre 600g y 2,500g en hasta diez sitios en EE. UU. El estudio evaluará la seguridad y eficacia del dispositivo durante seis meses como parte de la solicitud de aprobación previa al mercado.
El sistema Bloom está diseñado como una opción de tratamiento mínimamente invasiva, utilizando un sistema de entrega flexible para insertar un dispositivo de nitinol autoexpansible que bloquea el flujo sanguíneo a través del PDA. Actualmente, no hay un dispositivo aprobado para el tratamiento del PDA en bebés prematuros tan pequeños como 600 gramos.
Merit Medical Systems (NASDAQ: MMSI)는 조산아의 동맥관 개존증(PDA) 치료를 위한 Bloom Micro Occluder System의 PREEMIE 연구에 첫 번째 환자가 등록되었음을 발표했습니다.
이 다기관, 전향적 연구는 미국 내 최대 10개 사이트에서 600g에서 2,500g 사이의 조산아 최소 55명을 등록할 계획입니다. 이 연구는 시판 전 승인 신청의 일환으로 6개월 동안 장치의 안전성과 유효성을 평가할 것입니다.
Bloom 시스템은 PDA를 통한 혈류를 차단하는 자가 확장형 니켈-티타늄 장치를 삽입하기 위해 유연한 전달 시스템을 사용하는 최소 침습 치료 옵션으로 설계되었습니다. 현재 600그램만큼 작은 조산아의 PDA 치료를 위한 승인된 장치는 없습니다.
Merit Medical Systems (NASDAQ: MMSI) a annoncé l'inclusion du premier patient dans son étude PREEMIE, évaluant le Bloom Micro Occluder System pour le traitement du canal artériel persistant (PDA) chez les nourrissons prématurés.
L'étude multicentrique et prospective vise à inclure au moins 55 nourrissons prématurés pesant entre 600g et 2 500g dans jusqu'à dix sites aux États-Unis. L'étude évaluera la sécurité et l'efficacité du dispositif sur une période de six mois dans le cadre de la demande d'approbation préalable à la mise sur le marché.
Le système Bloom est conçu comme une option de traitement peu invasive, utilisant un système de livraison flexible pour insérer un dispositif en nitinol auto-expansible qui bloque le flux sanguin à travers le PDA. Actuellement, il n'existe aucun dispositif approuvé pour le traitement du PDA chez les nourrissons prématurés pesant aussi peu que 600 grammes.
Merit Medical Systems (NASDAQ: MMSI) hat die Rekrutierung des ersten Patienten für seine PREEMIE-Studie bekannt gegeben, die das Bloom Micro Occluder System zur Behandlung des persistierenden Ductus arteriosus (PDA) bei Frühgeborenen bewertet.
Die multizentrische, prospektive Studie zielt darauf ab, mindestens 55 Frühgeborene mit einem Gewicht zwischen 600g und 2.500g an bis zu zehn Standorten in den USA zu rekrutieren. Die Studie wird die Sicherheit und Wirksamkeit des Geräts über einen Zeitraum von sechs Monaten im Rahmen des Antrags auf Marktzulassung bewerten.
Das Bloom-System ist als minimalinvasive Behandlungsoption konzipiert und verwendet ein flexibles Abgabesystem, um ein selbstexpandierendes Nitinol-Gerät einzuführen, das den Blutfluss durch den PDA blockiert. Derzeit gibt es kein zugelassenes Gerät zur Behandlung des PDA bei Frühgeborenen mit einem Gewicht von nur 600 Gramm.
- First-to-market potential for PDA treatment in extremely small premature infants (600g)
- Addresses unmet medical need with no currently approved devices for this patient population
- Innovative minimally invasive technology with potential market advantage
- Product still in clinical trial phase with no guaranteed FDA approval
- initial market size of 55 patients in study
- Extended timeline for potential revenue generation due to 6-month evaluation period
Insights
Merit Medical's enrollment of the first patient in their PREEMIE study represents a strategic regulatory milestone in addressing an unmet clinical need. The IDE study will evaluate the Bloom Micro Occluder System in premature infants weighing as little as 600 grams - a population currently lacking FDA-approved device options for PDA closure.
The regulatory significance here is substantial. Merit is targeting a vulnerable patient population through the most rigorous FDA pathway (PMA), demonstrating commitment to generating robust clinical evidence. The planned enrollment of 55 patients across 10 US centers aligns with typical pediatric device study parameters for rare conditions.
From a competitive standpoint, Merit's approach is notable as they're not pursuing the easier 510(k) pathway but investing in generating the higher-quality data required for PMA approval. This creates a potential regulatory moat if successful, as competitors would need to conduct similar trials rather than claim substantial equivalence.
While initial patient enrollment marks just the beginning of what will likely be a multi-year regulatory process, Merit has positioned this device strategically within the FDA's pediatric device framework. The unmet need highlighted by the investigators strengthens the case for potential priority review consideration if outcomes are positive. The six-month evaluation period mentioned suggests a focused primary endpoint aimed at demonstrating early safety and efficacy.
Merit's PREEMIE study addresses a critical clinical challenge in neonatology. Patent ductus arteriosus (PDA) in premature infants can lead to significant complications including pulmonary overcirculation, heart failure, and compromised organ perfusion. Current treatment options are - surgical ligation is invasive with potential complications, while pharmacological approaches have variable efficacy and side effects.
The Bloom Micro Occluder's design features offer meaningful clinical advantages. The flexible delivery system is particularly important when navigating the delicate vasculature of extremely low birth weight infants. The streamlined procedure with reduced steps could minimize procedure time - a important factor in these fragile patients where prolonged interventions increase risk.
Including infants as small as 600g represents a significant advance. Current transcatheter devices are typically to larger infants, leaving the most vulnerable without minimally invasive options. The potential for bedside procedures mentioned by Dr. Forbes would eliminate transportation risks to catheterization laboratories.
The device's "softer design" suggests attention to the compliance mismatch between rigid occluders and delicate infant vasculature - a known complication risk. If proven safe and effective, this technology could shift the treatment paradigm toward earlier intervention rather than "watchful waiting," potentially preventing PDA-associated morbidities that affect long-term neurodevelopmental outcomes. The clinical impact extends beyond the procedural success to potential improvements in overall NICU outcomes for this high-risk population.
Multicenter, prospective study designed to evaluate safety and efficacy of Bloom™ Micro Occluder System for treatment of patent ductus arteriosus in premature infants
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
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Sarah Comstock
Merit Medical
+1-801-432-2864 | sarah.comstock@merit.com
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Westwicke - ICR
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