FlowMedical launches itm Rhenium-PTA/PTCA<sup>®</sup> and Receives Full CE-Certification
12 Oct 2008Itm FlowMedical GmbH, a medical device company focused on Endovascular Brachytherapy (EVBT), today announced the launch of its itm Rhenium-PTA/PTCA® for the treatment of constricted blood vessels (stenosis) using EVBT that combines medical effectiveness with safety for both the patient and the clinician. At the same time the Company announced that itm Rhenium-PTA/PTCA® received full CE-certification in September 2008 for use in cardiology and the peripheral vasculature. The treatment can be reimbursed by public and private insurers in Germany. itm FlowMedical GmbH will now commence marketing itm Rhenium-PTA/PTCA® within Germany and the European Union.
The itm Rhenium-PTA/PTCA® is a method for the safe and effective administration of EVBT to prevent stenosis and restenosis in blood vessels after conventional PTAs and PTCAs*. For many years EVBT has been considered to be an effective treatment but unfortunately EVBT treatments, primarily applied in cardiology, shared some fundamental common shortcomings. The itm Rhenium-PTA/PTCA® is the first method to allow safe and effective EVBT resolving these shortcomings.
First of all, the properties of the utilized isotope - Rhenium-188 – are such that clinical effectiveness can be achieved with a minimum of side effects. The emitted beta particles of Rhenium-188 have a very short path length and penetrate only a few millimeters into surrounding tissue. This means that when the beta radiation is delivered through the balloon catheter in the blood vessel at the point of the stenosis, it will irradiate only the immediate vessel wall with practically no radiation of surrounding tissue.
The catheter’s self-centering characteristics also ensure that the vessel walls are irradiated homogenously, making the treatment more medically efficient and, in contrast to previous EVBT and competitive treatments, itm Rhenium-PTA/PTCA® is versatile enough to treat extremely long and short lesions as well as vessels with small or large diameters.
When the treatment is complete after a few minutes, the short half life of Rhenium-188 ensures that residual radiation levels in used materials drop very quickly which significantly simplifies otherwise complicated waste management.
In addition, with the help of a specially developed generator, itm FlowMedical GmbH can produce the isotope on demand and, for the first time, in an activity concentration that is high enough to be used directly for treatment without any further after concentration, which further adds to the radiation safety and versatility of the method.
In the past the lack of appropriate application devices for EVBT has often compromised the safety of the clinicians and patients, exposing them to unnecessary radiation. itm Rhenium-PTA/PTCA® is constructed in such a way as to ensure maximum radiation protection for the doctor or nurse administering the treatment, while at the same time simplifiying the administration procedure. This is due to the specially developed application system (ASK), which allows interventions to be performed at extremely low levels of radiation exposure for both the patients and the clinicians. The device has been independently assessed by the German Federal Agency for Radiation Protection (BfS) which has found the device to be perfectly safe and appropriate for widespread use in routine clinical application.
“itm Rhenium-PTA/PTCA® is simple, effective and safe for both the patient and for doctors or nurses. For the first time we can treat a variety of different lesions, no matter whether they are extremely short or long or whether the vessels have large or small diameter,” said Hartmut Scheurer, President of itm FlowMedical GmbH. “This is particularly relevant to the treatment of peripheral vessels where there are currently no alternative means of treating stenosis and restenosis.”
itm Rhenium-PTA/PTCA® has already demonstrated effectiveness in a clinical setting. The Central Hospital, Augsburg has successfully applied the treatment to 50 patients since 2006, achieving excellent clinical results. 16 months after the treatment the restenosis rate is at only 13.6% - even when treating elderly, multi-morbid patients. This contrasts with conventional treatments like the Drug Eluting Stent or Drug-Coated Balloon, which show restenosis rates of 20% or higher within 6 months of the intervention in selective patients.
*PTA/PTCA: Percutaneous Transluminal (Coronary) Angioplasty