Biotronik said that its Dreams (Drug Eluting Absorbable Metal Scaffold) was successfully implanted in the first patient by professor Michael Haude at the Lukaskrankenhaus in Neuss, Germany, as part of the first-in-man clinical study Biosolve-I.
Biosolve-I is a prospective, non-randomized study that is expected to enroll patients in Germany, Belgium, The Netherlands and Switzerland.
Dreams technology combines the acute mechanical advantages of a metallic stent with an anti-proliferative drug, plus a reliable degradation profile that allows the vessel to slowly return to its natural physiology.
Biotronik said that the new device is made of a biodegradable Magnesium alloy combined with a slow release drug and is intended to open vessels and to keep them from re-clogging, while avoiding the longer term disadvantages associated with permanent metal stents.
Biotronik professor and head of the team that performed the first implant at the Lukaskrankenhaus in Neuss Michael Haude said that the first implantation went very well and he was excited to see how Dreams will show its efficacy in the follow-up and in future procedures of the Biosolve-I trial.
Biotronik considers Dreams to be the systematic next step forward after conventional PTCA, BMS (Bare Metal Stent) and DES (Drug Eluting Stent) technologies.
Biotronik vice president of marketing and sales Alain Aimonetti said that Dreams is different than a drug eluting stent as it offers a promising solution for currently unmet clinical needs. Many physicians anticipate that the absorbable aspect will initiate a true revolution in interventional cardiology.
“Looking at the vast amount of preclinical data, I am optimistic for the outcome of the study,” Aimonetti said.