Verheye Measures Whether Uncaging Compromises Deployment

Stefan Verheye designed the DynamX mechanistic study to answer what interventionalists needed to know first: whether they could trust the uncaging mechanism during deployment.

At ZNA Cardiovascular Center Middelheim in Antwerp, Belgium's largest healthcare organization, Verheye has authored over 170 peer-reviewed papers investigating new approaches and innovative technologies. He's evaluated coronary sinus reducers, bioresorbable magnesium scaffolds, sirolimus-coated balloons for in-stent restenosis. His assessment framework is consistent: Does deliverability match operator expectations? Does conformability adapt to vessel anatomy without compromise? Does radial strength provide predictable scaffolding?

Verheye measures robotic stent placement to fractions of millimeters—he told colleagues the R-One robotic arm "places the stent even more precisely than with the manual technique, down to a fraction of a millimeter." A device engineered to unlock needed to answer his handling questions before anyone cared about adaptive remodeling months later.

The Handling Verdict

After completing the 50-patient Belgian-Italian study, Verheye's assessment was direct:

At PCR e-Course 2020, he detailed what that meant: the bioadaptor "performs similarly to second-generation DES in terms of implantation technique, deliverability, conformability, and radial strength during the healing phase."

When asked specifically about deliverability during the BIOADAPTOR RCT presentation, his response was even more succinct:

For a device incorporating an uncaging mechanism, this validated the engineering challenge.

What Acute Performance Measured

Interventionalists need acute handling confidence during deployment. Verheye's mechanistic study captured this through outcome measures that translate to procedural confidence:

Acute Performance Metric	Result
Device and procedure success	100%
Acute lumen gain	1.61±0.34 mm
In-device diameter stenosis (post-implantation)	5.4±8.4%
Late lumen loss (12 months)	0.12±0.18 mm

The EuroIntervention publication confirmed what Verheye observed procedurally: "Until the uncaging, the DynamX bioadaptor functions like a conventional stent with similar deliverability, conformability and radial strength." The acute lumen gain and minimal residual stenosis indicated radial force comparable to metallic stents—the compression resistance enabling predictable vessel scaffolding during critical healing.

The device is constructed from cobalt-chromium with 71-micron struts—specifications matching contemporary DES platforms. The uncaging mechanism could have compromised acute vessel adaptation or created deployment uncertainty during the phase when interventionalists need predictable behavior most.

Verheye's study documented enhanced conformability post-uncaging, with patients showing approximately 50% return toward baseline angulation among those with ≥9° angulation change at follow-up. The acute phase conformability established the procedural familiarity that reduces deployment hesitation.

Why the Evaluator's Assessment Carries Weight

Verheye framed the device as designed to match "comparable characteristics with regard to thin struts, thin polymer coating, 'limus' drug, visibility, deliverability, radial strength, and clinical performance to contemporary metallic DES."

This emphasis on matching contemporary DES acute performance reflects strategic understanding: breakthrough mechanisms need conventional acute handling to gain adoption. The mechanistic study's late lumen loss of 0.12±0.18 mm in-device through 12 months demonstrated efficacy matching second-generation DES. Verheye's procedural observations—the deliverability, conformability, and radial strength assessments—established the foundation for that efficacy.

At PCR e-Course 2020, he positioned the significance:

The Procedural Foundation

Verheye's documented observations provided what breakthrough mechanisms need: confirmation that engineering innovation didn't create procedural trade-offs. His handling assessment confirmed interventionalists could deploy DynamX with the confidence contemporary DES platforms provide. The device also enables a different long-term trajectory through its adaptive remodeling.

The device designed to unlock had passed the test interventionalists needed answered first—matching acute performance during the phase when operator confidence determines adoption. Verheye's mechanistic study validated that a device could maintain conventional stent behavior during deployment and incorporate mechanisms for adaptive remodeling months later.

His assessment gave interventionalists permission to trust the device in their hands during deployment—to deploy with the handling characteristics they know. The device then enables vessel adaptation through its uncaging mechanism. When you measure precision to fractions of millimeters, that handling verdict carries weight.