Merit Medical Systems, Inc. MMSI, on Monday, announced the 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). The PREEMIE study is an Investigational Device Exemption study.
It should be noted that the Bloom Micro Occluder System is not currently approved to treat PDA.
MMSI plans to enroll at least 55 premature infants with hemodynamically significant or large PDA at up to 10 U.S. study sites. Eligible patients must weigh between 600 g and 2,500 g, which are considered “extremely low birth weight” and “low birth weight,” respectively. Merit Medical intends to evaluate safety and efficacy through six months as part of the premarket approval (PMA) application.
The commencement of the latest study is a significant stepping stone for Merit Medical, which is likely to strengthen its foothold in the global Cardiovascular space.
Significance of Merit Medical’s Study
Per Merit Medical, 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.
MMSI’s Bloom Micro Occluder System was designed as a minimally invasive option for treating hemodynamically significant PDAs. The PREEMIE study has been developed to evaluate its safety and efficacy.
Per an expert associated with the study, there is currently no approved device for PDA in premature infants weighing 600 grams. Hence, this study is expected to provide critical information for treating this high-risk population. The expert also believes that Bloom’s device design will likely enable safer and more effective care for these fragile patients.
Merit Medical’s management expects the PREEMIE study to have a critical role in improving care for many vulnerable premature infants, who would likely benefit from the closure of their PDA using a transcatheter device.
Industry Prospects in Favor of MMSI
Per a report by Data Bridge Market Research, the global PDA treatment market was valued at $2.4 billion in 2022 and is anticipated to reach $7.34 billion by 2030 at a CAGR of 15%. Factors like the rising demand for diagnostic tests and the increasing incidence of infants with PDA are likely to drive the market.
Given the market potential, the latest announcement of the commencement of enrollment is expected to solidify Merit Medical’s foothold in the niche space.
Merit Medical’s Notable Developments
Last month, Merit Medical reported its fourth-quarter 2024 results, wherein its Cardiovascular unit and all its product categories reported robust revenue growth.
In December 2024, Merit Medical announced that the WRAPSODY Cell-Impermeable Endoprosthesis had received the FDA’s PMA. With this approval, it can begin commercialization of the device in the United States in 2025.
Merit Medical, in November 2024, announced positive six-month findings from the single-arm Arteriovenous Graft cohort of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The WAVE trial was designed to assess the efficacy and safety of the WRAPSODY device.
Comparison With Peers
Merit Medical’s peer in the Cardiovascular space, Boston Scientific Corporation BSX, entered into a definitive agreement to acquire SoniVie Ltd. (a privately held medical device company that developed the TIVUS Intravascular Ultrasound System) this month. BSX aims to expand its Interventional Cardiology Therapies offerings with ultrasound-based renal denervation therapy for the treatment of hypertension.
Last month, Boston Scientific announced its fourth-quarter 2024 results, wherein it recorded a solid uptick in Cardiovascular revenues on a reported, operational and organic basis.
Another player and MMSI’s peer in the Cardiovascular space is AngioDynamics, Inc. ANGO. In January, ANGO announced the start of a Randomized Study of the Auryon Atherectomy System Used in Combination with Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects with Critical Limb Ischemia Below-the-Knee (AMBITION BTK).
The same month, AngioDynamics reported its second-quarter fiscal 2025 results, wherein it recorded robust Auryon, AngioVac, AlphaVac and NanoKnife disposable sales.
Another renowned peer in the Cardiovascular space is Medtronic plc MDT. This month, MDT released the two-year positive results of the Small Annuli Randomized To Evolut or SAPIEN (SMART) Trial, the largest international head-to-head comparative trial of transfemoral transcatheter aortic valve replacement.
Last month, Medtronic reported its third-quarter fiscal 2025 results, wherein its Cardiovascular Portfolio witnessed robust revenue uptick on both reported and organic basis.
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