BUELACH, Switzerland–(BUSINESS
WIRE)–BIOTRONIK AG announced that the six-month results of the
ENERGY Registry were presented last week by Prof. Raimund Erbel at the Transcatheter Cardiovascular Therapeutics (TCT 2011)
conference. This all-comers registry is investigating the safety and clinical
performance of the PRO-Kinetic Energy stent system in 1016 patients, including
a subanalysis with small vessels, diabetic and elderly patients.
“We are delighted that the ENERGY Registry supports our
belief that the PRO-Kinetic Energy stent is an excellent platform. For years we
have invested in continued development in our stent platforms, and these
outstanding results are a testament to our dedication.”
The ENERGY registry was conducted in 49 sites in 10
countries with patients who received a PRO-Kinetic Energy coronary bare metal
stent. The study population included a high number of patients with acute coronary syndrome (46%), almost 30% elderly patients
(?75 years), as well as highly complex lesions (39%). The primary endpoint was
six-month major adverse coronary events (MACE) defined as a composite of
cardiac death, clinically driven target lesion revascularization (TLR) and
myocardial infarction.
At six months, the PRO-Kinetic Energy stent system
demonstrated excellent clinical outcomes, with a MACE rate of only 4.4%.
Cardiac death, myocardial infarction, target lesion revascularization rates
were 0.6%, 1.3% and 2.5%, respectively. Only two cases of stent thrombosis
(0.2%) were seen. Also, in the small vessel (?2.75 mm) population, the very low
number of events was confirmed with a MACE rate of 6.4% and a TLR of only 2.8%.
“For the treatment of coronary artery lesions, it is crucial
to have a bare metal stent available that is not only highly deliverable, but
also safe and effective in a broad patient population-including elderly
patients and those presenting with acute coronary syndrome, stated Prof.
Raimund Erbel, principal investigator from the West German Heart Center in
Essen, Germany. “These six-month results are excellent.”
Alain Aimonetti, Vice President of Marketing and Sales at
BIOTRONIK AG added, “We are delighted that the ENERGY Registry supports our
belief that the PRO-Kinetic Energy stent is an excellent platform. For years we
have invested in continued development in our stent platforms, and these
outstanding results are a testament to our dedication.”
The PRO-Kinetic Energy is a thin strut (60?m), cobalt
chromium bare metal stent, completely sealed with a thin layer of amorphous
silicon carbide, PROBIO. This passive coating reduces the interaction between
the metal stent and the surrounding tissue, which makes the stent more
hemocompatible.
About BIOTRONIK SE & Co. KG
As one of the worlds leading cardiovascular medical device companies, with
several million implanted devices, BIOTRONIK is represented in over 100
countries with its global workforce of more than 5100 employees. Known for
having its finger on the pulse of the medical community, BIOTRONIK assesses the
challenges physicians face, and provides the best solutions for all phases of
patient care, ranging from diagnosis to treatment to patient management.
Quality, innovation and reliability define BIOTRONIK and its growing
success-and deliver confidence and peace of mind to physicians and their
patients worldwide. More information: www.biotronik.com
