NuMed’s 10-Zig Covered CP Stent Shows Procedural Efficiencies in Treating Congenital Heart Disease

April 30, 2021—An analysis of a new international registry reveals benefits of using a longer covered stent for interventional procedures in congenital heart disease patients with sinus venosus atrial septal defect (SVASD), announced the Society for Cardiovascular Angiography and Interventions (SCAI). The study was presented as late-breaking clinical research at the SCAI 2021 Virtual Scientific Sessions.

As noted by SCAI, the background of the study is that covered stent implantation has recently been developed interventional procedure that can replace open heart surgery in some of these patients. However, the study investigators advised that there is no “ideal stent” often leaving physicians to modify existing stents and frequently needing to “piggyback” several stents which adds to the difficulty and potential complications of the procedure.

In the study, investigators analyzed outcomes of the NuMed 10-zig covered CP (CCP) stent (NuMed, Inc.). The device is balloon expandable and intended for permanent implant in patients. It is composed of 0.013-inch platinum-iridium wire arranged in a 10-zig pattern that is laser welded at each joint and then over brazed with 24 karat gold. The 10-zig CCP stent was implanted in 75 patients (ages 11 to 75 years; median 45 years) from 12 centers. Preprocedural assessment included diagnostic catheterization in 30 patients, three-dimensional printed models in 34 patients, and virtual models in 13 patients.

SCAI reported that results showed 10-zig CCPs of 7 to 8 cm provided reliable SVASD closure with a low requirement for additional stents. An additional stent was placed in 4/5 (80%) with 5/5.5-cm CCPs, 18/29 (62%) with 6-cm CCPs; 5/18 (28%) with 7-cm CCPs, 5/22 (23%) with 7.5/8 cm CCPs, and 0/1 with an 11-cm CCP. Patients were followed from 3 weeks to 5 years.

Professor Eric Rosenthal, MD, served as lead study investigator of the study. Prof. Rosenthal is a pediatric and adult congenital cardiologist at Guy’s and St Thomas NHS Foundation Trust in London, United Kingdom.

“Our findings reveal that the novel, longer stents are a reliable advance in technology that significantly reduces the need for implantation of additional stents,” commented Prof. Rosenthal in the SCAI press release. “This helps to minimize many of the procedural risk factors and enhances the outcome. More SVASD patients will become eligible to undergo this novel interventional procedure and they will therefore avoid the need for open heart surgery.” Prof. Rosenthal concluded, “These encouraging results support the need for further research into the long-term benefits of the 10-zig stents while widening its use in patients with SVASD.”

The investigators noted that the longer covered stents are still investigational and require regulatory permission at most centers, stated SCAI.