Two innovations, side by side.
Pick two drugs or two devices and read them against each other, line for line. Every line comes from each one's primary source, and every comparison is a link you can send to a colleague.
Compare
- Bottom line
- Children who need a pulmonary valve replacement now have a surgical valve that can be enlarged by balloon catheter as they grow, which the FDA says may reduce the need for repeat open-heart surgeries. Data on expansion are limited and longer-term studies are under way.
- Interventional cardiologists have a sirolimus balloon option for in-stent restenosis that, per the company, helps minimize the need for another stent. The supporting trial showed non-inferiority to standard of care, which was mostly repeat drug-eluting stenting.
- FDA route
- Approved: Premarket approval (PMA), Oct 1, 2026The FDA's most demanding device review, for Class III devices that sustain life or carry the highest risk. It requires valid scientific evidence of safety and effectiveness, usually clinical studies, which are not always randomized.
- Approved: Premarket approval (PMA), Sep 21, 2026The FDA's most demanding device review, for Class III devices that sustain life or carry the highest risk. It requires valid scientific evidence of safety and effectiveness, usually clinical studies, which are not always randomized.
- Type
- Implant
- Therapy device
- What it is
- A surgically implanted pulmonary heart valve with polymeric leaflets instead of animal-derived tissue. It can be implanted as small as approximately 13 millimeters in diameter and later widened with a balloon catheter, up to 22 millimeters.
- A coronary angioplasty balloon that delivers sirolimus to the vessel wall. It is designed to provide sustained drug release for up to 90 days without leaving a permanent implant behind.
- Indicated for
- Pediatric patients with congenital pulmonary valve disease who need pulmonary valve replacement.
- Patients with coronary in-stent restenosis.
- What changes
- The FDA says traditional valves use animal-derived tissue, which tends to harden and break down faster in children and often requires earlier repeat surgery. The release does not describe the design of the clinical study.
- The SELUTION4ISR trial compared the balloon against standard of care, including 80% drug-eluting stents. The company describes it as a way to treat in-stent restenosis without leaving another permanent implant.
- Evidence
- Design not reported. At the six-month follow-up, the first 60 patients demonstrated acceptable hemodynamic performance with no more than mild leakage back through the valve. All patients had a successful procedure, with no deaths, blood clots requiring additional treatment, strokes or other clot-related complications.The source does not describe a clinical study or its design. Common for cleared devices, which can rest on equivalence to a predicate.
- Head-to-head randomized trial. At 12 months the study met its primary endpoint of non-inferiority in the per protocol population (16.2% for SELUTION SLR vs 14.5% for standard of care). In all randomized patients, target lesion failure rates were 15.2% for SELUTION SLR and 13.5% for standard of care.Randomized against an active treatment: the most direct evidence on how it compares with an existing option.
- Watch for
- Three patients had a fracture in the valve frame and two had reduced movement of one valve leaflet, none with symptoms. Valve performance began deteriorating in two patients who started to outgrow it; both were expanded successfully, but the FDA says the experience is limited and longer-term studies are being conducted.
- The release does not list contraindications, warnings or adverse events. The trial was a single-blind non-inferiority study, and the approval covers in-stent restenosis only; a separate 960-patient trial in de novo small-vessel lesions has completed enrollment but is not part of this approval.
- Setting and used by
- Not stated in the source
- Interventional cardiologists