MagicTouch ED:Sirolimus Coated Balloon Treatment for Erectile Dysfunction
MagicTouch ED - Concept Medical - Stent Manufacturer in Surat, India

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

ED is an important and growing health problem. lt is estimated that more than 200 million men (between 40 – 70 years) suffer from ED

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
Drug Sirolimus
Drug Dose 1.27 µg/mm²
Drug Carrier Phospholipid
Balloon
Balloon Material Polyamide
Catheter Design Rx/Monorail
Delivery System
Shaft Diameter (OD) Proximal : 1.8 F
Shaft Diameter (OD) Distal : 2.5 F
Usable Catheter Length 140cm
Tip Profile 0.016’’
Nominal Pressure 6 Bar
Rated Burst Pressure 16 Bar
Guiding Catheter Compatibility 5F
Guidewire Compatibility 0.014’’ 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
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
Age 59.8+10.8
BMI (kg/m2) 1.27 µg/mm²
Active Smoker(n,%) 8 (57)
Diabetes NID 5 (36)
Diabetes ID 4 (28)
Hypertension 9 (64)
Hypercholesterolemia 6 (42)
Family history for CAD 3 (21)
Coronary artery disease 4 (35)
Peripheral artery disease 3 (21)
History of prostate surgery 2 (14)
Chronic prostatitis 1 (7)
History of or current dialysis 0
Baseline IIEF-5 score 9.7+6.6
Q3: ability to achieve penetration 1.69+1.27
Q4: ability to maintain erection 1.18+1.23
Associated Venous leakage 1 (7)
Baseline medications tried before procedure
Phophodiesterase type 5 inhibitor 7 (50)
Prostaglandin, intracavernosal 6 (42)
Testosterone 3 (21)
Medications with an impact on EF
β-Blockers 3 (21)
Psychotropic drugs 0
Thiazide diuretics 2 (14)

Lesion and Procedural Characteristics

Target lesion(n=18)
Internal iliac artery (n,%) 3 (16)
Internal pudendal artery 11 (62)
Common penile artery 2 (12)
Dorsal penile artery 1 (5)
Cavernosal artery 0
Inferior gluteal artery 1 (5)
Arteries affected
Left side only 5 (27)
Right side only 6 (33)
Bilateral 7 (40)
Arteries treated
Left side only 9 (50)
Right side only 7 (38)
Bilateral 2 (12)
Lesion length, mm 11.9±6.6
Total lesion length, mm 17.6±13.3
RVD, mm 2.2±0.5
Diameter stenosis, % 68.0±6.5
 MLD, mm 1.4±0.6`
PSVb, cm/s 19.5±10.9
EDVb, cm/s 8.9±5.4
Endovascular intervention
Standard balloon dilation 18 (100)
Drug-eluting stent 3 (16)
Sirolimus-coated balloon 15 (84)
No access 1 (5)
Procedural Success (stenosis <10%) 17 (94)
“Confidence Through Evidence”
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