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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. 

Contact Information:

Concept Medical Research Private Limited.
concept@conceptmedicals.com

Source: Concept Medical Inc.