TAMPA, Fla., May 29, 2023 /PRNewswire/ -- The US FDA, on
the 24th of May 2023,
granted an Investigational Device Exemption (IDE) approval for
Concept Medical Inc's Sirolimus Coated Balloon (SCB) MagicTouch PTA
for the treatment of Superficial Femoral Arteries (SFA). This marks
the fourth IDE approval for the Company's Sirolimus coated
balloon.
The Company has already received three other pivotal IDE
approvals for its SCB MagicTouch family of products for the
coronary In-Stent Restenosis (ISR), Coronary Small Vessel and
Below-the-Knee indications.
Lower extremity Peripheral Arterial Disease (PAD) affects an
estimated quarter million adults in Europe and North
America and is associated with significant morbidity and
mortality, with atherosclerosis being the main cause. Stenosed and
occluded SFA remain major contributors to the PAD.
The IDE approval will allow Concept Medical to initiate pivotal
clinical study to demonstrate safety and effectiveness of the
MagicTouch PTA Sirolimus coated balloon in femoral and popliteal
segments. The data generated from this IDE clinical study will
support a future pre-market approval (PMA) application in the
USA.
MagicTouch PTA is the world's first Sirolimus coated balloon
with extensive commercial usage in Europe, major markets of Asia and the Mid-Eastern markets. It is also
the most clinically studied Sirolimus Drug Coated Balloon (DCB) for
PAD treatment, which includes the largest head-to-head RCT against
Paclitaxel DCB, and the largest RCT against uncoated balloon.
Presently, the treatment options for PAD are limited to uncoated
PTA balloons, paclitaxel coated DCBs and a DES, thus restricting
the physician's choice and alternatives for patients. Uncoated
balloons have been identified with substandard results post
intervention due to recurrent re-narrowing of arteries, and
Paclitaxel safety remains a debate due to association of the drug
with long-term mortality. Sirolimus which has already proven safety
in coronary artery disease treatment, will fill this gap in PAD of
safety and efficacy in near future.
"We are extremely proud to have received the 4th IDE
approval from the USFDA for MagicTouch PTA in the SFA indication,"
said Dr. Manish Doshi, Founder and
M.D. - Concept Medical Group. "This milestone underscores our
unwavering commitment to advancing medical technology and providing
innovative solutions that have the potential to transform patient
care."
About MagicTouch PTA:
MagicTouch PTA is a CE approved and commercially marketed
Sirolimus coated balloon outside the
United States of America for the treatment of de-novo,
stenotic and in-stent restenotic lesions in Superficial Femoral
(SFA), popliteal, Below The Knee (BTK) and iliac arteries, using
proprietary Nanoluté Technology.
About Concept Medical Inc. (CMI):
CMI is headquartered in Tampa,
Florida and has operational offices in The Netherlands, Singapore and Brazil and manufacturing units in India. CMI specializes in developing unique
combination products with patented coating technology that can
deliver any drug / pharmaceutical agent across the luminal surfaces
of blood vessels.
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Logo:
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