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TAMPA, Fla., Jan. 7, 2025 /PRNewswire/ -- Concept Medical Inc., a global leader in innovative drug-delivery technology, proudly reports positive outcomes from the SIRONA (Head-to-Head Comparison of SIROlimus versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery) RCT, which show that its sirolimus-coated balloons (SCB) (MagicTouch -PTA) provide patency and functional benefits on par with paclitaxel-coated balloons for patients suffering from peripheral artery disease (PAD). The 1-year data was presented by Principal Investigator Prof. Ulf Teichgräber at the TCT USA 2024 conference in a Late–Breaking Clinical Trials Session (LBCT). Coverage by TCTMD has highlighted these findings, underscoring sirolimus-based therapy as a viable new option in femoropopliteal interventions.
The prospective, multi-center, head-to-head, core lab adjudicated RCT enrolled a total of 482 patients across 25 sites in Germany and Austria and compared the MagicTouch PTA sirolimus-coated-balloon against 7 commercially available paclitaxel-coated-balloons.
Key Results
- Primary Patency: SIRONA concluded that a primary patency of 73.8% was achieved by MagicTouch PTA against 75% of Paclitaxel DCBs showing a mere rate difference of 1.2% and meeting the non-inferiority efficacy endpoint of primary patency.
- Favorable Safety Profile: SIRONA demonstrates no significant difference in cdTLR (clinically-driven Target Lesion Revascularization) at 12 months, 92.9% (MagicTouch PTA) and 95.4% (Paclitaxel group).
- Functional Improvements: SIRONA showcased similar improved functional outcomes with both Sirolimus and Paclitaxel groups with a 0.1 difference between them and 89% improving by ≥1 Rutherford stage and many by ≥2 stages.
"Historically, paclitaxel-coated balloon angioplasty has been the mainstay therapy for PAD, particularly in the femoropopliteal vascular segment, and is based on the 'leaving nothing behind' principle. However, safety concerns remain, so that emerging evidence supports the exploration of sirolimus as alternative drug option in the treatment of PAD. With the SIRONA RCT showing sirolimus to be as effective as paclitaxel, physicians may soon have more personalized approaches to address the wide-ranging needs of PAD patients," said Prof. Ulf Teichgräber.
Prof. Dierk Scheinert, who has been supporting and encouraging the RCT stated after the exciting results, "After several positive signals from pre-clinical studies and smaller single arm investigations with sirolimus coated DCBs, the findings of the SIRONA RCT using the Head-to-Head randomization design represent the first level one evidence to support clinical efficacy of the Magic Touch sirolimus-coated DCB for a broad spectrum of femoropoliteal obstructions."
"Concept Medical has consistently pursued innovation in vascular therapy," said Dr. Manish Doshi, Founder & Managing Director of Concept Medical. "The results of the SIRONA trial advance our mission to offer patient-centric, evidence-based solutions that improve the care and outcomes of those challenged by PAD."
About Concept Medical
Headquartered in Tampa, Florida, Concept Medical is a world leader in cutting-edge drug-delivery platforms. Its flagship MagicTouch Sirolimus Coated Balloon (SCB) has reshaped the landscape of coronary and peripheral interventions, reaching more than a million patients globally by continuously investing in rigorous clinical research—exemplified by the SIRONA trial—Concept Medical remains at the forefront of developing next-generation vascular therapies.
For more information on the SIRONA trial or Concept Medical's innovative portfolio of devices, please visit: www.conceptmedical.com
TAMPA, Fla., Jan. 7, 2025 /PRNewswire/ -- Concept Medical Inc., a global leader in innovative drug-delivery technology, proudly reports positive outcomes from the SIRONA (Head-to-Head Comparison of SIROlimus versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery) RCT, which show that its sirolimus-coated balloons (SCB) (MagicTouch -PTA) provide patency and functional benefits on par with paclitaxel-coated balloons for patients suffering from peripheral artery disease (PAD). The 1-year data was presented by Principal Investigator Prof. Ulf Teichgräber at the TCT USA 2024 conference in a Late–Breaking Clinical Trials Session (LBCT). Coverage by TCTMD has highlighted these findings, underscoring sirolimus-based therapy as a viable new option in femoropopliteal interventions.
The prospective, multi-center, head-to-head, core lab adjudicated RCT enrolled a total of 482 patients across 25 sites in Germany and Austria and compared the MagicTouch PTA sirolimus-coated-balloon against 7 commercially available paclitaxel-coated-balloons.
Key Results
- Primary Patency: SIRONA concluded that a primary patency of 73.8% was achieved by MagicTouch PTA against 75% of Paclitaxel DCBs showing a mere rate difference of 1.2% and meeting the non-inferiority efficacy endpoint of primary patency.
- Favorable Safety Profile: SIRONA demonstrates no significant difference in cdTLR (clinically-driven Target Lesion Revascularization) at 12 months, 92.9% (MagicTouch PTA) and 95.4% (Paclitaxel group).
- Functional Improvements: SIRONA showcased similar improved functional outcomes with both Sirolimus and Paclitaxel groups with a 0.1 difference between them and 89% improving by ≥1 Rutherford stage and many by ≥2 stages.
"Historically, paclitaxel-coated balloon angioplasty has been the mainstay therapy for PAD, particularly in the femoropopliteal vascular segment, and is based on the 'leaving nothing behind' principle. However, safety concerns remain, so that emerging evidence supports the exploration of sirolimus as alternative drug option in the treatment of PAD. With the SIRONA RCT showing sirolimus to be as effective as paclitaxel, physicians may soon have more personalized approaches to address the wide-ranging needs of PAD patients," said Prof. Ulf Teichgräber.
Prof. Dierk Scheinert, who has been supporting and encouraging the RCT stated after the exciting results, "After several positive signals from pre-clinical studies and smaller single arm investigations with sirolimus coated DCBs, the findings of the SIRONA RCT using the Head-to-Head randomization design represent the first level one evidence to support clinical efficacy of the Magic Touch sirolimus-coated DCB for a broad spectrum of femoropoliteal obstructions."
"Concept Medical has consistently pursued innovation in vascular therapy," said Dr. Manish Doshi, Founder & Managing Director of Concept Medical. "The results of the SIRONA trial advance our mission to offer patient-centric, evidence-based solutions that improve the care and outcomes of those challenged by PAD."
About Concept Medical
Headquartered in Tampa, Florida, Concept Medical is a world leader in cutting-edge drug-delivery platforms. Its flagship MagicTouch Sirolimus Coated Balloon (SCB) has reshaped the landscape of coronary and peripheral interventions, reaching more than a million patients globally by continuously investing in rigorous clinical research—exemplified by the SIRONA trial—Concept Medical remains at the forefront of developing next-generation vascular therapies.
For more information on the SIRONA trial or Concept Medical's innovative portfolio of devices, please visit: www.conceptmedical.com
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Concept Medical Announces Successful SIRONA Trial Results, Demonstrating Sirolimus-Coated Balloon as a Promising Alternative for PAD Treatment
BEIJING, Jan. 11, 2026 /PRNewswire/ -- On December 29, the "Forging the Path to National Strength: China's Manufacturing Achievements Under the 14th Five-Year Plan," jointly organized by the National Museum of China and the Ministry of Industry and Information Technology, officially opened at the National Museum of China, showcasing more than 300 top national achievements. GAC's "National Outstanding Engineer Team" successfully developed both the Magazine Battery and the Solid-State Battery, which were selected for the exhibition.
The GAC Magazine Battery is the first battery system to pass both the nail penetration no-flame and non-ignition safety tests. By utilizing ultra-high intrinsic safety cells, an all-weather "vehicle-end + cloud-based" active safety monitoring system, and a multi-dimensional safety protection system, the Magazine Battery achieves three layers of protection: core, active, and passive. Its safety performance far exceeds the electric vehicles traction battery safety requirements (GB38031-2025), which will take effect on July 1, 2026. Currently, the Magazine Battery has a cumulative deployment of 1.3 million vehicles with zero spontaneous combustion and over 50 billion kilometers of safe travel, providing users with robust safety assurance for every journey.
GAC's self-developed large-capacity solid-state battery has achieved an energy density exceeding 400 Wh/kg and easily passes rigorous safety tests such as 200°C thermal chamber and nail penetration tests, effectively addressing users' range anxiety and safety concerns. Innovations in materials and processes have placed the solid-state battery at the forefront of the industry in key indicators such as safety, energy density, and cycle life, providing a superior power solution for the future development of NEVs. Currently, a pilot production line for GAC's solid-state battery has been established, capable of mass-producing vehicle-grade solid-state batteries over 60 Ah, marking a critical step toward the goal of full vehicle integration by 2026.
Over the years, GAC has been steadily enhancing its competitiveness through innovations across intelligent connectivity, NEV powertrains technologies, and forward-looking technologies. Looking ahead, GAC will continue to deepen its efforts in the intelligent connected NEV field, leveraging more leading technological achievements to drive industry progress.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
GAC Magazine Battery and Solid-State Battery Win Top National Honor
