Device: Biotronik's Drug Eluting Absorbable Metal Scaffold (DREAMS)
CE mark: No
European clinical trials: Yes, primary endpoint expected in December 2014
Biotronik's DREAMS is the most differentiated stent because it consists of bioresorbable magnesium alloy rather than the lactic acid polymer used by competitors. The stent should have improved deliverability and a lower risk of fracturing because its material is stronger than that of its polymer competitors, said GlobalData's Priya Madhavan, pointing to study results showing that 97% of DREAMS' scaffolds had not separated from the vessel wall after one year--a better apposition rate than Abbott's ($ABT) offering.
But being the first to use metal may also explain why Biotronik is unlikely to be the first (or even the second) to bring its product to the market, because DREAMS remains clinically unproven. It started the Biosolve-II trial in 2013 after the initial Biosolve trial showed that DREAMS was not as effective as Abbott's Absorb. After Biosolve-I, Mark Johnson, program director for Biotronik's U.S. vascular intervention department, told FierceDrugDelivery that paclitaxel is "not the optimal drug" for the device. The second trial tests the device's elution of limus (which coats the metallic body along with a polymer matrix), in line with competitors. Madhavan said this is the most important change, citing studies that show limus-based drugs are superior to paclitaxel.
|Biotronik's DREAMS--Courtesy of Biotronik|
The primary endpoint of Biosolve-II is in segment late lumen loss at 6 months, according to ClinicalTrials.gov. The product demonstrated late lumen loss in Biosolve-I at one year, according to a Biotronik release. In contrast, the CE-marked polymer competitors demonstrated late lumen gain, meaning the area within the blood vessel continued to increase in the months after the surgery. DREAMS passed its primary endpoint in Biosolve-I, demonstrating a rate of target lesion failure of 6.8% at two years. And there were no cardiac deaths or cases of stent thrombosis (which involve stent blockage due to a blood clot), Biotronik said.
Due to the possible superiority of its material, the differentiated DREAMS has the potential to gain a lot of market share. But, as every sports scout knows, potential is a dangerous thing. Whether the stent will obtain a CE mark or require more testing will be clear soon enough; data collection for the new primary endpoint concludes by year's end.
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