Optimed’s sinus-Venous and sinus-Obliquus Venous Stents Evaluated in Prospective Multicenter Trials

June 7, 2022—Optimed, an interventional technology company based in Ettlingen, Germany, announced presentations on two prospective multicenter trials evaluating the performance and effectiveness of the company’s CE Mark–approved venous stent systems: sinus-Obliquus and sinus-Venous.

sinus-Obliquus

Two-year results from the TOPOS trial of Optimed’s sinus-Obliquus device for the treatment of postthrombotic syndrome (PTS) were presented by Tim Sebastian, MD, with the University Hospital Zurich in Zurich, Switzerland. Houman Jalaie, MD, presented the design and preliminary data from the STEVECO trial of the sinus-Venous system. Dr. Jalaie, the STEVECO Principal Investigator, is with the European Venous Center Aachen-Maastricht, the University Hospital in Aachen, Germany, and the University of Maastricht in Maastricht, the Netherlands. The presentations were delivered at LINC 2022, the Leipzig Interventional Course held June 6-9 in Leipzig, Germany.

According to the company, TOPOS is a prospective, multicenter, single-arm study that included patients with PTS and iliofemoral venous outflow obstruction.

At 24 months, TOPOS had a primary stent patency rate of 81% and a secondary patency rate of 96%. Patients in the study had a mean stent length of 22 cm, with 70% of stents extending beyond the inguinal ligament. The lesion length was longer in comparison to other prospective venous stent trials, noted the press release.

Additionally, patients sustained a reduction in disease severity and improvement in quality of life at 24 months. TOPOS did not include patients with nonthrombotic iliac vein lesions, in which patency rates are typically higher than in thrombotic disease, advised Optimed.

“We are very encouraged by the durable vessel patency; reduction in symptoms; and reversal of physical, social, and psychological impairment caused by PTS,” commented Dr. Sebastian in Optimed’s press release. “In particular, this was a challenging PTS study population, with the majority of patients requiring multiple stents extending below the inguinal ligament.”

According to Optimed, the STEVECO trial is a prospective, randomized, multicenter 12-month trial comparing venous stenting using the sinus-Venous stent versus conservative treatment. The study is measuring quality of life, venous disease severity, and patency. The population includes patients with both PTS and nonthrombotic iliac vein lesions.

sinus-Venous

“STEVECO demonstrates meaningful quality-of-life improvement comparing venous stenting to conservative treatment in a randomized study,” reported Dr. Jalaie in the press release. “This will be important evidence to share with our physician colleagues as we seek individualized treatment for our patients.”

Optimed’s sinus-Obliquus is a purpose-built venous stent featuring a unique bevel for placement at the origin of the vena cava, a high strength closed-cell segment for the iliac compression, and a flexible segment for the external iliac. The sinus-Venous is a highly flexible, open-cell venous stent with independent power rings providing strength. The sinus-Venous device may be deployed in the iliac and femoral veins or as an extension stent to the sinus-Obliquus, stated the company.