Study: Biotronik's dissolving stent deemed safe, falls short of Abbott's Absorb

In the wake of Abbott Laboratories' ($ABT) initiation of a large clinical trial for its Absorb dissolvable drug-eluting stent, the smaller Biotronik is inching its way to a spot in the emerging market. But carving out that niche has proven difficult for the private German company.

Despite a successful run of early human trials, Biotronik's DREAMS (drug eluting absorbable metal scaffold) stent showed to be less effective than Abbott's Absorb in the controlled release of the restenosis drug paclitaxel--its ability to maintain a viable vascular channel after one year in a patient was not as apparent as the Absorb's, according to the study as reported in HeartWire.

Biotronik remains optimistic, though, based on the results of the early trial, which showed 100% procedural success at 6 months and only 7% failure at 12 months. Mark Johnson, program director for Biotronik's U.S. vascular intervention department, told FierceDrugDelivery that paclitaxel is "not the optimal drug" for the device, and the company is conducting a clinical trial in Europe using a limus-based version of the stent.

The difference between the two stents is that, rather than the polymer-based scaffolding in the Absorb model, Biotronik's stent is made primarily of magnesium, which is designed to break down in the body over time. Johnson said the advantage of magnesium is that, as a metal, it more closely mimics traditional nondissolving stents, which have a proven track record.

"We're very pleased with the results," Johnson said. "We continue to improve it, develop different iterations before we market it."

Johnson said Biotronik is weighing its options as it moves forward with further clinical trials.

- here's the study (sub. req.)
- read the report (reg. req.)