BIOTRONIK DREAMS implanted in first patient as part of BIOSOLVE-I clinical study

BIOTRONIK SE & Co. KGAug 13 2010

Vascular Intervention

“The first implantation went very well and I am excited to see how DREAMS will show its efficacy in the follow-up and in future procedures of the BIOSOLVE-I trial.”

A significant milestone has been reached in the development of a new therapy for patients suffering from coronary artery disease. On July 27, 2010 the BIOTRONIK DREAMS (Drug Eluting Absorbable Metal Scaffold) was successfully implanted in the first patient by Prof. Dr. Michael Haude at the Lukaskrankenhaus in Neuss, Germany as part of the first-in-man clinical study BIOSOLVE-I.

DREAMS technology is revolutionary in that it combines for the first time, 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. 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.

Prof. Dr. Michael Haude, head of the team that performed the first implant at the Lukaskrankenhaus in Neuss has commented, "The first implantation went very well and I am excited to see how DREAMS will show its efficacy in the follow-up and in future procedures of the BIOSOLVE-I trial."

Stents are frequently required after an obstructed artery has been re-opened by an angioplasty. Permanent drug-eluting stents are made of non-degradable metals which remain in the body life-long and are associated with potential complications such as late stent thrombosis. The safety and biocompatibility of bare Magnesium scaffolds have been proven in previous BIOTRONIK studies. As a global pioneer in absorbable Magnesium, BIOTRONIK has refined this technology for more than 10 years based on physicians' input to deliver the optimal balance between vessel scaffolding, degradation profile and drug elution characteristics.

BIOTRONIK considers DREAMS to be the systematic next step forward after conventional PTCA, BMS (Bare Metal Stent) and DES (Drug Eluting Stent) technologies. Alain Aimonetti, Vice President Marketing and Sales with BIOTRONIK, has commented "DREAMS is different than a drug eluting stent - 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 our vast amount of preclinical data, I am optimistic for the outcome of this study."

BIOSOLVE-I is a prospective, non-randomized study that will enroll patients in Germany, Belgium, The Netherlands and Switzerland. Investigators and participating centers are Clinical Coordinating Investigator (CCI) Dr. Jacques Koolen and Dr. Brueren at the Catharina-Ziekenhuis Eindhoven, Netherlands, Prof. Erne and Dr. Jamshidi at the Luzerner Kantonsspital, Switzerland, Prof. Haude and Dr. Degen at the Lukaskrankenhaus Neuss, Germany, Prof. Hehrlein at the Uniklinik Freiburg i.Br., Germany, Dr. Verheye and Dr. Vermeersch at the Akademisch Ziekenhuis Middleheim, Belgium and Prof. Erbel and Dr. Eggebrecht at the Uniklinik Essen, Germany. Prof. Erbel was also the PI of the previous clinical trial PROGRESS-1 that studied the performance of the un-coated absorbable metal scaffold and provided critical information for further development of the technology. Further enrollment in BIOSOLVE-I is planned to begin with all centers shortly.