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August 20, 2020

Long-Term Outcomes With Getinge’s Advanta V12 Balloon-Expandable Covered Stent Supported in Study

August 20, 2020—Getinge announced that a new study reinforces the long-term outcomes of the company’s Advanta V12 covered balloon-expandable (CBE) stent. Bibombe Patrice Mwipatayi, MD, et al conducted a systematic literature review of studies of CBE stents for the treatment of aortoiliac occlusive disease (AIOD). The findings were published online in Journal of Vascular Surgery.

“Each covered stent has a different design and technology, which means that it needs to be proven efficient and safe in its own trial,” commented Dr. Mwipatayi in Getinge’s announcement. “According to our analysis, long-term data is only available for a single device, the Advanta V12, with results favorable through 5 years.” Dr. Mwipatayi is with the Perth Institute of Vascular Research, University of Western Australia, in Perth, Australia.

Study investigator Jean-Paul de Vries, MD, with the University Medical Center Groningen in the Netherlands, added, “Real-world data [are] essential to demonstrate longevity of performance. In the past, there have been devices that looked positive in the first year, but after 2 or 3 years the patency dropped off dramatically.”

The review included 15 published articles of 14 clinical studies of different CBE stents for AIOD, including Getinge’s Advanta V12/iCast devices. Eight of the study were prospective clinical trials and six were retrospective real-world studies.

According to Getinge, the studies of the Advanta V12/iCast devices were composed of 611 patients, compared to 12 to 164 patients for the other reviewed devices. The duration of follow-up was between 8 and 60 months for Advanta V12 compared with up to 12 months for the other stents.

The technical success, patency, and freedom from target lesion revascularization (TLR) at 12 months were similar among the reviewed devices. However, Advanta V12 is the only device with data out to 5 years, with primary patency of 74.7%.

The Advanta V12/iCast studies included real-world studies with patients with more severe disease (defined as the percentage of total occlusions and lesion length) as compared with patients who received other stents. Advanta V12/iCast–treated patients also included a greater number of TASC C/D lesions than studies of other devices. Additionally, long-term data for primary patency and freedom from TLR is currently only available for the Getinge device.

Getinge’s Advanta V12 is indicated for restoring and improving the patency of the iliac and renal arteries. Renal approval includes 5-, 6-, and 7-mm diameter sizes. The Advanta V12 has Canadian Health Ministry license for restoring the patency of iliac lesions; approval in Canada excludes renal arteries. The Advanta V12 Stent is not available in the United States. The company’s iCast covered stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms, advised the company.

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