The INFINITY-SWEDEHEART trial is a large-scale, multi-center randomized controlled trial designed to evaluate the safety, effectiveness, and long-term outcomes of the DynamX Coronary Bioadaptor compared to a contemporary drug-eluting stent. Enrolling 2,400 patients, it is the largest randomized controlled trial to evaluate the drug-eluting bioadaptor system versus a contemporary drug-eluting stent.
The INFINITY-SWEDEHEART study confirms the safety and effectiveness of the DynamX coronary bioadaptor in a broad patient population representative of everyday clinical practice. More than 76% of this patient population presented with Acute Coronary Syndrome (ACS).
This study provides large-scale, real-world evidence on the performance of the DynamX Coronary Bioadaptor in a broad patient population. Its size and national registry integration enable evaluation of long-term outcomes and clinical effectiveness in routine clinical practice.
Furthermore, favorable outcomes for the Bioadaptor in the high-risk subgroup of acute coronary syndrome, and consistent benefit in prespecified subgroups were observed.
These results confirm the novel impact of the Bioadaptor in CAD treatment through its unique mechanism of action of restoring the hemodynamic modulation of a diseased artery.
INFINITY-SWEDEHEART is the largest and second RCT to confirm consistency of low and plateauing adverse event rates versus DES after the unlocking of the Bioadaptor at 6 months.
The trial compares the DynamX Coronary Bioadaptor to a contemporary drug-eluting stent using a 1:1 randomized controlled design.
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One of the largest clinical trials evaluating an alternative to drug-eluting stents is the INFINITY-SWEDEHEART trial, which studied the DynamX coronary bioadaptor in 2,400 patients. This randomized controlled trial compared DynamX to a leading drug-eluting stent (Resolute Onyx™ DES) in a representative, clinically complex ischemic patient population, including those with acute coronary syndrome (ACS).
Yes. The INFINITY-SWEDEHEART trial was designed to reflect everyday clinical practice, not just controlled conditions.
The study included:
The results provide strong real-world evidence that DynamX performs safely and effectively across a wide range of patients.
In the INFINITY-SWEDEHEART clinical trial of the DynamX Coronary Bioadaptor, the 6-month mark represents a critical turning point:
The INFINITY-SWEDEHEART trial specifically analyzed outcomes from 6 months onward to capture this effect.
Target Lesion Failure (TLF) is a composite measure that includes:
In the INFINITY-SWEDEHEART trial:
Event rates in studies of patients who have undergone percutaneous coronary intervention (PCI) typically refer to major adverse coronary events or MACE.
With drug-eluting stents, multiple studies report a rising event rate over the five years after the procedure.
Plateauing event rates means that:
In the INFINITY-SWEDEHEART trial:
The study evaluates clinical endpoints such as target lesion failure (TLF), major adverse cardiac events (MACE), and long-term patient outcomes, along with additional assessments of vessel function and performance.
PMN 2501 Rev A
PMN 1777 Rev A
