Date: 25 February, 2021
Outcomes of a prospective multicenter non-randomized registry for the safety and effectiveness of the hydrophilic coated guiding catheter PRIMUM in Trans Radial Percutaneous Coronary Intervention (TR-PCI).
Wellinq announces the publication of a Performance Analysis of a Novel Hydrophilic-Coated Transradial Guiding Catheter in Clinical Cardiology and Cardiovascular Interventions journal on February 18, 2021.
The PRIMUM Hydrophilic coated guiding catheter (manufactured by PendraCare B.V. a Wellinq company, Leek, The Netherlands) has a hydrophilic-coated segment of approximately 7 cm proximal from the tip until 25 cm distal from the hub. To facilitate optimal alignment and backup support the segment of the tip is uncoated. The proximal 25 cm of the catheter is designed to prevent unintentional movement of the catheter during the procedure. Hydrophilic coating provides no “stick-slip” effect, allowing more accurate and precise tip positioning in ostial lesions, and a 1:1 torque control of the tip.
A subset of 217 patients included in the ARCUS registry (Effect of Transradial percutaneous coronary intervention on upper extremity function) were treated using the 6F PRIMUM guiding catheter. The aim of the prospective guiding catheter study was to assess the safety and effectiveness, and whether it could lead to favorable outcomes with TRA. The study reports the overall performance and safety of the catheter up to 6-months follow-up.
The average number of guiding catheters was 1.2 per patient. Procedure success rate was 97.7%. The study shows far better outcomes of spasm in the radial artery compared to only using 6F hydrophilic-coated sheaths. 8.8% was reported as “Moderate” spasm and only 1.8% in “Severe” spasm, compared with the moderate to severe spasm rate of 19% when using only 6F hydrophilic-coated sheaths only.
This registry indicates that the 6F PRIMUM guiding catheter to show high eligibility for use in TR-PCI. Use of the hydrophilic-coated PRIMUM catheter as a default system in routine TR-PCI was both feasible and safe, associated with high procedural success and low complication rates. In addition, the short and long-term MACCE outcomes of the PCI were favorable.
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.