A novel Sirolimus coated balloon catheter assists angioplasty of small coronary artery lesions in coronary artery disease (CAD).

The Concept Medical (CMI; Tampa, FL, USA) MagicTouch Sirolimus Coated Balloon (SCB) catheter is intended for use in percutaneous transluminal coronary angioplasty (PTCA) of small coronary artery lesion 6 - 36mm in length, and with diameters of 1.50 - 2.75mm. The SCB delivers the Sirolimus within 60 seconds to the vessel wall, which is released over 30 days. After PTCA, patients have to take continue an antibiotic regimen for 45 days, as compared to an antiplatelet therapy course following stent placement, which takes around one or two years.

MagicTouch SCB uses Nanolute technology, which increases Sirolimus lipophilicity by encapsulating it a phospholipid. The process involves conversion of Sirolimus into sub-micron sized particles, and then encapsulating them. Inflation of the MagicTouch SCB at the target site transfers these nanocarriers to the vessel wall, via the principle of co-efficient diffusion; once exposed to body pH, the nanocarriers mimic body lipids, liberating the miniscule Sirolimus drug particles, which penetrate the deepest layer of the vessel over a period of time.

“The biggest challenge in developing MagicTouch was that Sirolimus was an unstable molecule with weak binding properties, thereby making it difficult to ‘stick’ to the balloon,” said Manish Doshi, PhD, founder, president, and CEO of Concept Medical. “It took years of research to master the Limus drug delivery platform technology to devise an innovative product like MagicTouch.”

Each of the three main arteries supplying blood to the cardiac musculature branches into progressively smaller vessels that eventually penetrate the cardiac musculature. Occlusion of coronary microvascular vessels can diminish blood flow to the heart leading to angina, with symptoms of chest pain, shortness of breath, and diffuse chest discomfort, but without the angiographic signs of atherosclerosis. Known as coronary microvascular dysfunction (CMD), it is more prevalent in women, especially after menopause.  

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