MagicTouch ED:Sirolimus Coated Balloon Treatment for Erectile Dysfunction
MagicTouch ED - Concept Medical - Developing technologies for drug delivery with a strong emphasis on intellectual property.

Erectile dysfunction (ED) is defined as the recurrent inability to achieve and maintain an erection satisfactory for sexual intercourse.

Sirolimus Coated

Balloon Catheter

MagicTouch ED

Assuring Safety by Delivering Sirolimus

  • TECHNOLOGY - MagicTouch ED

    TECHNOLOGY

    An innovative proprietary Nanolute technology providing better bioavailability of SIROLIMUS

  • COATING - MagicTouch ED

    COATING

    Unique coating technology leads to 100% balloon surface coating

  • DRUG - MagicTouch ED

    DRUG

    Sirolimus: A drug with proven safety profile

  • CARRIER - MagicTouch ED

    CARRIER

    A biocompatible phospholipid drug carrier improving the adhesion property of Sirolimus

Nanolute Technology

NANOLUTE TECHNOLOGY is designed to improve the lipophilicity and bioavailability of Sirolimus

  • Phospholipid is a drug carrier with two lipophilic tails and one hydrophilic head.
  • Sirolimus is encapsulated in phospholipid with proprietary Nanolute technology.

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Unique Coating Technology

Drug carrier along with drug is coated on the unfolded balloon to achieve 100% coating on balloon surface
Unique and proprietary refolding mechanism facilitates better crossing profile

TECHNICAL SPECIFICATION

Drug / Excipient
DrugSirolimus
Drug Dose1.27 µg/mm²
Drug CarrierPhospholipid
Balloon
Balloon MaterialPolyamide
Catheter DesignRx/Monorail
Delivery System
Shaft Diameter (OD)Proximal : 1.95 F
Shaft Diameter (OD)Distal : 2.67 F
Usable Catheter Length140cm
Tip Profile0.016’’
Nominal Pressure 8 Bar
Rated Burst Pressure14 Bar
Guiding Catheter Compatibility6F
Guidewire Compatibility0.014’’ Maximum recommended
Size Available
Balloon Length (mm)10, 15, 20 , 25, 30, 35, 40
Balloon Diameter (mm)1.50, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00

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MagicTouch ED

Vasculogenic Erectile Dysfunction – Case by Prof. Sangiorgi

Case of Pudendal artery angioplasty has been performed by Prof. Sangiorgi and his team from San Gaudenzio Hospital – Novara, Italy. During the case Co2 cavernosography was performed in a 49 years old male with no major cardiovascular risk factors & not responding since 2 years to PDE5i. The arteriography revealed fibrosis of the cavernous bodies related to complete absence of bilateral opacification with Co2 of the cavernosal tissue.

Different therapeutic options were evaluated in an another case of vasculogenic erectile dysfunction showing a diffuse atherosclerotic disease of a right mid and distal segment of pudendal artery in a 65 year old male which was treated with DES implantation and Sirolimus eluting balloon with prolonged inflation with optimal final angiographic result (see picture).

CLINICAL EVIDENCE

Patients’ Baseline characteristics

No. of patients, N=14
Age59.8+10.8
BMI (kg/m2)1.27 µg/mm²
Active Smoker(n,%)8 (57)
Diabetes NID5 (36)
Diabetes ID4 (28)
Hypertension9 (64)
Hypercholesterolemia6 (42)
Family history for CAD3 (21)
Coronary artery disease4 (35)
Peripheral artery disease3 (21)
History of prostate surgery2 (14)
Chronic prostatitis1 (7)
History of or current dialysis0
Baseline IIEF-5 score9.7+6.6
Q3: ability to achieve penetration1.69+1.27
Q4: ability to maintain erection1.18+1.23
Associated Venous leakage1 (7)
Baseline medications tried before procedure
Phophodiesterase type 5 inhibitor7 (50)
Prostaglandin, intracavernosal6 (42)
Testosterone3 (21)
Medications with an impact on EF
β-Blockers3 (21)
Psychotropic drugs0
Thiazide diuretics2 (14)

Lesion and Procedural Characteristics

Target lesion(n=18)
Internal iliac artery (n,%)3 (16)
Internal pudendal artery11 (62)
Common penile artery2 (12)
Dorsal penile artery1 (5)
Cavernosal artery0
Inferior gluteal artery1 (5)
Arteries affected
Left side only5 (27)
Right side only6 (33)
Bilateral7 (40)
Arteries treated
Left side only9 (50)
Right side only7 (38)
Bilateral2 (12)
Lesion length, mm11.9±6.6
Total lesion length, mm17.6±13.3
RVD, mm2.2±0.5
Diameter stenosis, %68.0±6.5
 MLD, mm1.4±0.6`
PSVb, cm/s19.5±10.9
EDVb, cm/s8.9±5.4
Endovascular intervention
Standard balloon dilation18 (100)
Drug-eluting stent3 (16)
Sirolimus-coated balloon15 (84)
No access1 (5)
Procedural Success (stenosis <10%)17 (94)
Sr. NoStudy NameType of StudyTarget PatientsCountryClinical Trials Identifier
Sr. No:  1Study Name:   Suasion Registry Type of Study:  Target Patients:  100Country:  ItalyClinical Trials Identifier:  https://clinicaltrials.gov/ct2/show/NCT04345965
Sr. No:  2Study Name:   LIBIDO RCT Type of Study:  Target Patients:  64Country:  Italy, Switzerland, Germany, Grecia, LithuaniaClinical Trials Identifier:  
“Confidence Through Evidence”
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