Bentley Announces First-in-Human Implantation of BeGrow Stent System
July 9, 2018—Bentley announced that the first-in-human placement of the company's BeGrow stent system was performed in a 24-day-old infant. The device, for treating babies with congenital heart disorders, is designed to grow with the child to alleviate pulmonary artery stenosis.
The procedure, which marks the initiation of the BeGrow clinical trial, was performed by Principal Investigator Professor Oliver Kretschmar, MD, an interventional pediatric cardiologist with the Kinderspital Zurich, Switzerland.
The BeGrow clinical study is a prospective, multicenter, explorative, open-label, single-arm study to assess the safety and performance of the BeGrow stent system for newborns and infants with pulmonary artery stenosis. The trial started in March 2018 and is due for completion in 2021.
According to the company, the BeGrow stent system will be indicated for intraluminal placement in the pulmonary arteries of newborns and infants for the treatment of pulmonary artery stenosis. BeGrow is balloon expandable with a low, crimped profile that can be inserted and dilated at minimal pressure via the 4-F–compatible catheter to a 6-mm–expanded diameter, the width of a newborn's pulmonary artery. The stent has lengths of 10, 13, 17, 20, and 24 mm.
The device is designed to fit a newborn’s 6-mm–diameter pulmonary artery. At approximately 8 to 10 years of age, it can be postdilated to a vessel diameter of 11.5 mm. Beyond this diameter, the stent breaks open at predetermined points in a controlled way.
The primary outcome measures are vessel enlargement directly after the procedure and during follow-up to 12 months. A total of 18 infants will be included. All enrolled patients will undergo primary stenting of the target lesion by placement of the BeGrow stent system.
The company advised that it will submit an application for European CE Mark approval immediately after the 12-month results of primary outcome measures are available and will continue to gather long-term results of efficacy and safety for device recipients up to 8 to 10 years of age.
In the company's press release, Prof. Kretschmar commented, "We have been looking for something to fulfill the need for a stent that can grow with the vessel from infant to child to adult. With BeGrow, the stent ‘breaks open in a controlled way’ when it has been dilated to a diameter > 11.5 mm, after which it is designed to grow with the child’s vessel, as pig studies have shown. If needed, we could place an adult-width stent in the pulmonary artery while BeGrow remains in situ.”
Prof. Kretschmar noted that the clinical trial results would determine the preferred course of action in the long term. He added, “The benefit of BeGrow is that the stent can stay in the patient for the rest of their life. Even if we add in another stent of adult size, it is certain that we will not have to surgically remove the BeGrow, like we do with other current off-label solutions, inherently carrying a risk of vessel damage.”