|Biotronik's DREAMS--Courtesy of Biotronik|
Biotronik announced that the second clinical trial of its Dreams drug-eluting bioresorbable stent met another milestone as it races to become the third player in the emerging space.
The Biosolve-II trial has completed enrollment, the company said. Its primary outcome measure is late lumen loss at 6 months, according to ClinicalTrials.gov.
There have been plenty of hiccups along the way to the continued goal of CE-mark approval to market the device in Europe and other emerging markets that accept the CE mark.
Biotronik initiated the Biosolve-II trial in 2013 after the initial Biosolve trial showed that Dreams was not as effective as Abbott's ($ABT) bioresorbable stent, Absorb. Following the Biosolve-I flop, Mark Johnson, program director for Biotronik's U.S. vascular intervention department, previously 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.
A Biotronik spokeswoman pointed out that the Dreams was deemed safe in the Biosolve-I trial.
Initially, the company had a primary completion date for Biosolve-II of January 2015, according to ClinicalTrials.gov, meaning it aimed to finalize data collection of the primary outcome measure by then. It has not met that deadline due to delays in the enrollment stage. Previously, the trial's site on ClinicalTrials.gov said the deadline for completion of primary data collection was December 2014. The 121-patient trial commenced in October 2013.
Abbott's Absorb BVS and Elixir's DESolve 100 are the only CE-marked bioresorbable stents, meaning they are available commercially in Europe. There are no bioresorbable stents available in the U.S., making it an example of the kind of device that the FDA's critics say should be approved faster in the U.S. Abbott aims to secure coveted FDA approval for the Absorb in the coming years; its Absorb II trial is scheduled to announce the results of its primary endpoint (vessel motion) in July 2016.
Biotronik's Dreams is differentiated 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, former GlobalData analyst Priya Madhavan previously told FierceMedicalDevices, 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 offering.
Drug eluting bioresorbable stents are designed to be absorbed by the body after about a year, and expected to provide a trio of medical benefits over today's drug-eluting stents, which stay in the body permanently: a reduction in restenosis, or renarrowing of the arteries, which results from the body's inflammation response to foreign materials; a continued increase in the size of the coronary artery in the months following the surgery (late lumen gain); and the return of vasomotion, or the vessel's reversion to its original, prediseased state.
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Special Report: Leaders emerge in the race for the first U.S. bioresorbable stent - Is Biotronik's DREAMS close to becoming reality?