MagicTouch™ sirolimus coated calloon: one year clinical outcomes
Insights from Nanolutè prospective registry
EuroPCR 2017, Paris, France: The 1‐year clinical outcome the NANOLUTÈ study, a prospective Indian registry, has been recently reported during the latest EuroPCR 2017 held in Paris. Dr. Bernardo Cortese (Intv’ Cardiology, A.O. Fatebenefratelli ,Milano, Italy) set the scene by first outlining the limitations of current percutaneous coronary interventions “In last two decades, there has been a progressive development in catheter based technologies used to treat the coronary artery disease. Initial results of plain balloon angioplasty were encouraging but were limited by suboptimal results and reduced long term patency. The introduction of drug eluting stents (DES) lowered the rates of restenosis. Despite such a great trial data, in the setting of more complex coronary disease like treating small vessels, in‐stent restenosis, bifurcation lesions etc., DES restenosis rates are higher. The more recent development of drug coated balloon therapy offers the potential for sustained anti‐restenotic efficacy, without the limitation of permanent vascular implants.”
Titled “One year clinical outcomes of percutaneous treatment with world’s first Sirolimus eluting balloons: Results from Nanolutè prospective registry” the article presents the results of analyses of patient‐level data from the NANOLUTÈ clinical program, which enrolled a total of 408 patients who received a MagicTouchTM Sirolimus Coated Balloon as participants in study conducted in India.
In NANOLUTÈ study, almost half of the patients presented with diabetes mellitus (44.36%) and acute coronary syndrome (47.55%). Results showed high procedural success rate of 99.51%. SCB‐only strategy was employed in a great proportion of the cases (93.14%). There were no procedural deaths reported and the overall 12‐month major adverse cardiac event (MACE) was 4.61% (14 cases of TLR, 1 case of myocardial infarction and 1 case of cardiac death).
Sirolimus coated balloon is indicated for lesions in small vessels, in‐stent restenosis (ISR) and bifurcation lesions. Subgroup analyses for both small vessel and ISR groups were performed. Results revealed that MACE rate in small vessel group was 4.06% at 12 months with no myocardial infarction reported while in ISR group; MACE was reported as 6.17% at 12 months with no cardiac death reported. The strong performance of the MagicTouch SCB in patients with small vessels and ISR in real‐world clinical practice advances the growing body of evidence that warranted the device's efficacy and safety.
Dr. Cortese concluded: “SCB might constitute a new therapeutic option in the setting of complex coronary lesions, also considering the good deliverability and tractability of SCB. Good results were reported in complex patients like with SVD and ISR supports its efficacy”.
Looking to the future, he commented “Ad hoc, powered studies are an indispensible tool for assessing the preliminary results in the western world population”. “The EASTBOURNE registry: thE All‐comers Sirolimus‐coaTed BallOon eURopeaN rEgistry coordinated by our center (Dr. Cortese is the Chairman for this study with Dr. Antonio Colombo, San Raffaele Hospital, Milano, Italy) has been initiated successfully. It is a real world registry having the target of enrolling 1000 patients treated with SCB at various interventional cardiology sites across Europe. The purpose of this study is to observe and evaluate the performance of a SCB for the treatment of any type of coronary lesions, including native vessel disease and in‐stent restenosis. Enrollment started in September 2016, and more than 150 patients have been enrolled to date. Moreover, we are designing an ad hoc randomized clinical trial of comparison with current‐era drug‐eluting stent", said Dr. Cortese.
About MagictouchTM SCB:
MagicTouchTM is a Sirolimus drug coated balloon catheter for the treatment of the coronary artery disease, indicated for in‐stent restenosis, small vessels and bifurcation lesions. It is designed using the concept of NANOLUTETM technology. It is nano‐carrier based effective drug delivery technology which creates larger surface area to volume ratio hence improving the bioavailability of the drug.
About Concept Medical Research Private limited:
Concept Medical Inc. (CMI) is establishment of USA. CMI was founded in year 2008, having the mission of “converting concepts into reality” in the field of drug delivering medical devices industry. Concept Medical Research Private Limited (CMRPL) is India based research division of CMI, which is dedicated for research and development of drug delivering medical devices in various medicinal application including cardiovascular and peripheral medical devices. The company is currently developing novel drug for oncology application.
Concept Medical Research Private Limited.
Source: Concept Medical Inc.