Q&A: ‘First of its kind’ stent for neonates, very young with pulmonary stenosis approved
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Key takeaways:
- The FDA approved a novel mini stent designed to treat branch pulmonary artery stenosis or coarctation of aorta in the very young.
- The first commercial use of the device was at Children’s Hospital Los Angeles.
In August, the FDA approved a novel miniaturized cardiac stent for infants and small children with coarctation of the aorta or pulmonary artery stenosis and can be expanded as they grew.
Two days after the FDA approval, Children’s Hospital Los Angeles announced its first commercial use in a press release.
As Healio previously reported, the first-in-human implantation of the novel stent (Minima, Renata Medical) was done Feb. 1, 2022, at Children’s Hospital Los Angeles in a 5-month-old boy born with two congenital heart defects, dextro-transposition of the great arteries and coarctation of the aorta. The procedure was the first in a multicenter early feasibility study to test the efficacy and safety of the device.
The FDA approval was based on the results of a pivotal trial that enrolled 42 patients across seven sites in the U.S. According to the release, 97.6% of patients had effective relief from their stenosis; no additional surgical interventions for stent dysfunction were required; and there were no major adverse events at 6 months.
The stent is mounted and crimped onto a balloon within a unique catheter and can be crimped down to less than 2 mm and the stent can be expanded from 5 mm up to 24 mm as the child grows, according to the release.
Healio spoke with Darren P. Berman, MD, director of congenital interventional catheterization with the Heart Institute at Children’s Hospital Los Angeles, about the device and its use in the very young population.
Healio: Can you please provide some background on why this mini expandable stent might be superior to balloon angioplasty in this patient population?
Berman: Balloon angioplasty remains an option for treatment of branch pulmonary artery stenosis or coarctation of aorta. However, the results of balloon angioplasty are generally not as good as stent therapy and less predictable. In older patients that are bigger, we would often times skip balloon angioplasty all together and place a stent to treat branch pulmonary artery stenosis or coarctation of aorta because the results are superior. We have not been able to do this for smaller patients because we have not had the correct stent options. Going forward, balloon angioplasty will still play a role in some patients and would be attempted first. If the result is adequate, that subset of patients would not need a stent. But in the many that fail balloon angioplasty, we would then be able to proceed with using this new technology.
Healio: Who is the ideal patient to receive this kind of stent?
Berman: This stent and its delivery system have been specifically designed for neonates — less than 30 days old — infants — 1 month to 1 year — and small children who have branch pulmonary artery stenosis or coarctation of aorta. The ideal patient will be many. It could be an infant patient who underwent complex heart surgery to fix a congenital heart defect and then has residual or recurrent problem with either branch pulmonary artery stenosis or coarctation of aorta. This stent can be used to treat them instead of them needing to undergo another surgery. This is just one example.
Healio: How is this stent with regard to durability and anticipated long-term outcomes as these children grow into adulthood?
Berman: This is a great question. The initial 42 patients that received this stent are going to be followed long-term. The durability of the stent beyond 1 to 2 years is not truly known at this time because we don’t have enough data to answer this. The technology is so new. There are other stents made of similar metals and extrapolating from that, we expect the long-term durability to be good but we don’t have that answer as of yet. The bench testing of the stent shows excellent results — assessing ‘stent fatigability’.
Healio: Anything else you would like to add about the stent and/or its recent FDA approval?
Berman: This stent’s approval marks a huge milestone in the care of patients with congenital heart disease. Stents have been used for approximately 30 years to treat vascular stenoses and never before has a stent been specifically designed for our smallest patients. This is the first of its kind.
For more information:
Darren P. Berman, MD, can be reached at 4650 Sunset Blvd., Los Angeles, CA 90027.
References:
- FDA approves first-of-its-kind cardiac stent for babies. https://www.chla.org/blog/experts/research-and-breakthroughs/fda-approves-first-its-kind-cardiac-stent-babies. Published Sept. 11, 2024. Accessed Oct. 7, 2024.
- Minima stent system – P240003. https://www.fda.gov/medical-devices/recently-approved-devices/minima-stent-system-p240003. Published Sept. 20, 2024. Accessed Oct. 7, 2024.
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