Date: 26 February, 2021
Outcomes of an Interim Analysis Real-world Registry (PEARL) for the safety and effectiveness of coronary Drug Eluting Balloons, Protégé and Protégé NC* (Wellinq Holding B.V.), in patients with a higher cardiovascular risk profile and mainly high complex lesions.
Wellinq announces the publication of the Interim Analysis of the Protégé and Protégé NC Paclitaxel-Eluting Balloons in Real-World Practice (PEARL). The 6-month results of 200 patients were published in Clinical Cardiology and Cardiovascular Interventions journal on February 08, 2021.
The Protégé and Protégé NC (Manufactured by Blue Medical Devices B.V. a Wellinq company, Helmond, The Netherlands) have an unique balloon design in which the drug component, incorporated in a hydrophilic coating, is encapsulated in the balloon folds and is only exposed upon inflation.
The innovative Paclitaxel loading Technology of Wellinq Protégé DEB ensures precise drug loading between the balloon wings and minimises drug exposure on the surface of the folded balloon. Wing seal technology guarantees even tight lesion crossing without premature drug release.
Moreover single Protégé and Protégé NC allow multiple usage due to reproduceable delivery of Paclitaxel into the vessel, for example of long defused lesions (>25 mm).
“One could hypothesize that a single Protégé DEB could be utilized multiple times in the same or even another coronary lesion, leading to less procedure time and total costs.”
– Quote by Dr. A.J.J. IJsselmuiden, Amphia hospital, department of Cardiology, Breda, The Netherlands.
The Interim Analysis of the first 200 consecutive patients in the multicentre PEARL Registry affirms that the use of the Protégé DEB is safe and effective for PCI of in-stent restenosis and de novo lesions in patients with a higher cardiovascular risk profile.
Patients were enrolled at 4 hospitals in the Netherlands. DEB was primarily used for in-stent restenosis in 73.5% of patients and for de novo lesions in 26.5% of patients.
A total of 242 lesions were treated with DEB. The majority of lesions had a high complexity with 34% classified as type B2 and 46% classified as type C. Protégé with pre-dilatation was performed in 62%. Protégé NC without pre-dilatation was used in 38%. The availability of a unique non-compliant version of the Protégé DEB means that pre-dilatation may not always be required.
DEB related procedural complications were low (6.5%), mostly consisting of coronary dissection (n=12). Final angiographic and clinical success was achieved in all patients.
None of the patients had a major adverse cardiac event (MACE) during hospitalization.
The final PEARL Registry analysis is currently in progress of 500 patients with 2-years follow-up.
* NC- non compliant
Wellinq is a global medical device company focused on the development and manufacturing of high-quality products used in (cardio)vascular end markets through major Medical Device OEM customers and distributors around the world. Wellinq is headquartered in Leek, The Netherlands, and has multiple locations in Leek and Helmond for our business units Vascular Medical Devices and Sensor Solutions. At Sensor Solutions we build sensor technology that is integrated into our medical devices and independent medical and industrial applications. The accumulated engineering skills and in-house manufacturing capabilities combined with the go-get mentality of its workforce make Wellinq a thriving specialized enterprise. We take great pride in breaking new ground for the benefit of doctors and patients. No matter what