Skip to Content Facebook Feature Image

Concept Medical Announces Successful SIRONA Trial Results, Demonstrating Sirolimus-Coated Balloon as a Promising Alternative for PAD Treatment

Business

Concept Medical Announces Successful SIRONA Trial Results, Demonstrating Sirolimus-Coated Balloon as a Promising Alternative for PAD Treatment
Business

Business

Concept Medical Announces Successful SIRONA Trial Results, Demonstrating Sirolimus-Coated Balloon as a Promising Alternative for PAD Treatment

2025-01-07 20:14 Last Updated At:20:35

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

Concept Medical Announces Successful SIRONA Trial Results, Demonstrating Sirolimus-Coated Balloon as a Promising Alternative for PAD Treatment

LAS VEGAS, Jan. 12, 2026 /PRNewswire/ -- Roborock, the global leader in home robotics engineered to simplify daily life, became the most awarded Robotic Vacuum Brand at CES 2026, after announcing its new product line-up for the first half of the year. Under the theme "The Greatest Meeting the Greatest", the brand's keynote presentation led by Roborock's President, Quan Gang, unveiled the Saros Rover, the world's first robotic vacuum with AI-powered wheel-leg architecture that can both navigate stairs and slopes with human-like agility while cleaning them.

Announcements also included the Roborock Saros 20, Roborock Saros 20 Sonic, Roborock F25 ACE Pro, and Roborock Qrevo Curv 2 Flow. These launches happened in partnership with Real Madrid Football Club for the Vacuum Cleaner category, announced ahead of the show's starting date.

Roborock also announced separate to the Real Madrid partnership its entry into the US market for lawnmower products, including the new RockMow X1 LiDAR. Consumers, clients, and interested parties can visit Roborock's Booth #52632 at Venetian Expo CES 2026 from January 6 to January 9th during show hours.

Roborock Saros Rover - The World's First Wheel-Leg Robovac

In a world-first, Roborock introduced at CES 2026 the Roborock Saros Rover, featuring the world's first two-wheel-leg architecture in a robovac. Each wheel-leg provides reach, lift, height, and imitates human mobility, enabling the robot to raise and lower each one of the wheel-legs independently, execute small jumps, agile turns, sudden stops, and directional changes, all while maintaining a level body as the ground changes.

At a software level, Saros Rover harnesses the power of Artificial Intelligence algorithms, in conjunction with complex motion sensors and 3D spatial information to understand its environment and make its wheel-legs react with precision.

The Saros Rover excels in multi-storey homes, where it is able to clean each one of the steps of a staircase as it goes to the second floor, dramatically reducing "no-go" zones and transitioning into cleaning areas previously inaccessible for homes with a single robovac.

The Saros Rover is able to tackle several types of non-flat surfaces, with staircases being the most obvious one. This includes not only traditional staircases but also curved staircases, or even carpeted staircases with bullnose fronts, all while cleaning each one of their steps as it navigates through them. Other types of surfaces that Saros Rover is able to tackle include slopes as well as complex multi-level room thresholds requiring height and power.  Saros Rover is a real product in development with an unconfirmed launch date.

The Greatest Meeting The Greatest - Roborock and Real Madrid Football Club join hands

Announced days before the show's beginning, Roborock presents at CES its first activation within the strategic global partnership with Real Madrid Football Club's First Men and First Women teams, widely ranked as one of the greatest football clubs in history. The partnership is solely related to Roborock's extensive portfolio of Vacuum Cleaner products and excludes other product lines from the brand. Under the umbrella theme of "The Greatest Meeting The Greatest", the partnership responds to a deep affinity between the brand ethos of both organizations, which have achieved remarkable historical performance with innovation as common denominator. The partnership will bring Roborock's smart-cleaning innovations to life through stadium exposure, campaigns and player-led storytelling that translate the meaning of "Real Smart Cleaning" from the pitch to the home.

Roborock's early 2026 Robovac line-up: Roborock Saros 20, Roborock Saros 20 Sonic, and Roborock Qrevo Curv 2 Flow

At its keynote, Clarbi Lu, product marketing lead at Roborock, unveiled new smart cleaning products launching in the first half of the year. Leading the lineup are the Roborock Saros 20 and Roborock Saros 20 Sonic, the latest flagship models in the Saros Series. Saros 20 upgrades the StarSight™ Autonomous System 2.0 with enhanced AI object recognition and a new AdaptiLift Chassis 3.0 for improved threshold climbing. Saros 20 Sonic adds RetractSense™ Navigation, an ultra-slim body, and the VibraRise® 5.0 Mopping System. Both use a 35,000 Pa HyperForce® motor and a new RockDock®. The Qrevo Series also expands with the Roborock Qrevo Curv 2 Flow.

Rockmow X1 LiDAR, X1, RockNeo Q1 lead the Roborock North American Roll-Out of Lawnmowers

Roborock has announced its North American expansion into the lawnmower category with three key models. The flagship RockMow X1 LiDAR features Sentisphere™ LiDAR Environmental Perception, 4WD traction, and Active Steering for flawless coverage. Alternatively, the RockMow X1 utilizes RTK and VSLAM navigation alongside a Dynamic Suspension System for industry-leading edge cutting. For smaller gardens, the entry-level RockNeo Q1 makes smart care accessible by combining RTK + VSLAM navigation with Stereo Vision Obstacle Avoidance.

For pricing and availiability, please contact your local Roborock sales or communications representative.

About Roborock

Roborock is a leading smart cleaning brand renowned for its intelligent cleaning solutions. Having become the #1 best-selling robotic vacuum cleaner brand according to IDC*, Roborock enriches lives with its innovative line of robotic, cordless, wet/dry vacuum cleaners, robotic lawn mowers and washer-dryers. Rooted in a user-centric approach, our R&D-driven solutions cater to diverse cleaning needs in millions of homes across more than 170 countries and regions. Headquartered in Beijing and with strategic subsidiaries in key markets, including the United States, Japan, the Netherlands, Poland, Germany, and South Korea, Roborock is dedicated to elevating its market presence worldwide. As of 2026, Roborock serves more than 22 million households. For more information, visit https://global.roborock.com/.

LAS VEGAS, Jan. 12, 2026 /PRNewswire/ -- Roborock, the global leader in home robotics engineered to simplify daily life, became the most awarded Robotic Vacuum Brand at CES 2026, after announcing its new product line-up for the first half of the year. Under the theme "The Greatest Meeting the Greatest", the brand's keynote presentation led by Roborock's President, Quan Gang, unveiled the Saros Rover, the world's first robotic vacuum with AI-powered wheel-leg architecture that can both navigate stairs and slopes with human-like agility while cleaning them.

Announcements also included the Roborock Saros 20, Roborock Saros 20 Sonic, Roborock F25 ACE Pro, and Roborock Qrevo Curv 2 Flow. These launches happened in partnership with Real Madrid Football Club for the Vacuum Cleaner category, announced ahead of the show's starting date.

Roborock also announced separate to the Real Madrid partnership its entry into the US market for lawnmower products, including the new RockMow X1 LiDAR. Consumers, clients, and interested parties can visit Roborock's Booth #52632 at Venetian Expo CES 2026 from January 6 to January 9th during show hours.

Roborock Saros Rover - The World's First Wheel-Leg Robovac

In a world-first, Roborock introduced at CES 2026 the Roborock Saros Rover, featuring the world's first two-wheel-leg architecture in a robovac. Each wheel-leg provides reach, lift, height, and imitates human mobility, enabling the robot to raise and lower each one of the wheel-legs independently, execute small jumps, agile turns, sudden stops, and directional changes, all while maintaining a level body as the ground changes.

At a software level, Saros Rover harnesses the power of Artificial Intelligence algorithms, in conjunction with complex motion sensors and 3D spatial information to understand its environment and make its wheel-legs react with precision.

The Saros Rover excels in multi-storey homes, where it is able to clean each one of the steps of a staircase as it goes to the second floor, dramatically reducing "no-go" zones and transitioning into cleaning areas previously inaccessible for homes with a single robovac.

The Saros Rover is able to tackle several types of non-flat surfaces, with staircases being the most obvious one. This includes not only traditional staircases but also curved staircases, or even carpeted staircases with bullnose fronts, all while cleaning each one of their steps as it navigates through them. Other types of surfaces that Saros Rover is able to tackle include slopes as well as complex multi-level room thresholds requiring height and power.  Saros Rover is a real product in development with an unconfirmed launch date.

The Greatest Meeting The Greatest - Roborock and Real Madrid Football Club join hands

Announced days before the show's beginning, Roborock presents at CES its first activation within the strategic global partnership with Real Madrid Football Club's First Men and First Women teams, widely ranked as one of the greatest football clubs in history. The partnership is solely related to Roborock's extensive portfolio of Vacuum Cleaner products and excludes other product lines from the brand. Under the umbrella theme of "The Greatest Meeting The Greatest", the partnership responds to a deep affinity between the brand ethos of both organizations, which have achieved remarkable historical performance with innovation as common denominator. The partnership will bring Roborock's smart-cleaning innovations to life through stadium exposure, campaigns and player-led storytelling that translate the meaning of "Real Smart Cleaning" from the pitch to the home.

Roborock's early 2026 Robovac line-up: Roborock Saros 20, Roborock Saros 20 Sonic, and Roborock Qrevo Curv 2 Flow

At its keynote, Clarbi Lu, product marketing lead at Roborock, unveiled new smart cleaning products launching in the first half of the year. Leading the lineup are the Roborock Saros 20 and Roborock Saros 20 Sonic, the latest flagship models in the Saros Series. Saros 20 upgrades the StarSight™ Autonomous System 2.0 with enhanced AI object recognition and a new AdaptiLift Chassis 3.0 for improved threshold climbing. Saros 20 Sonic adds RetractSense™ Navigation, an ultra-slim body, and the VibraRise® 5.0 Mopping System. Both use a 35,000 Pa HyperForce® motor and a new RockDock®. The Qrevo Series also expands with the Roborock Qrevo Curv 2 Flow.

Rockmow X1 LiDAR, X1, RockNeo Q1 lead the Roborock North American Roll-Out of Lawnmowers

Roborock has announced its North American expansion into the lawnmower category with three key models. The flagship RockMow X1 LiDAR features Sentisphere™ LiDAR Environmental Perception, 4WD traction, and Active Steering for flawless coverage. Alternatively, the RockMow X1 utilizes RTK and VSLAM navigation alongside a Dynamic Suspension System for industry-leading edge cutting. For smaller gardens, the entry-level RockNeo Q1 makes smart care accessible by combining RTK + VSLAM navigation with Stereo Vision Obstacle Avoidance.

For pricing and availiability, please contact your local Roborock sales or communications representative.

About Roborock

Roborock is a leading smart cleaning brand renowned for its intelligent cleaning solutions. Having become the #1 best-selling robotic vacuum cleaner brand according to IDC*, Roborock enriches lives with its innovative line of robotic, cordless, wet/dry vacuum cleaners, robotic lawn mowers and washer-dryers. Rooted in a user-centric approach, our R&D-driven solutions cater to diverse cleaning needs in millions of homes across more than 170 countries and regions. Headquartered in Beijing and with strategic subsidiaries in key markets, including the United States, Japan, the Netherlands, Poland, Germany, and South Korea, Roborock is dedicated to elevating its market presence worldwide. As of 2026, Roborock serves more than 22 million households. For more information, visit https://global.roborock.com/.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

Recommended Articles