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Business Upturn
6 days ago
- Business
- Business Upturn
Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe
Concept Medical announces first patient enrollment in MAGICAL-SV IDE trial, expanding its Coronary Clinical Program across the U.S. and Europe. Business Wire India Concept Medical Inc. , a global pioneer in drug-delivery technologies, announced the enrollment of the first patient in the MAGICAL-SV (MAGIcTouch™ Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels) trial, a U.S. Investigational Device Exemption (IDE) study evaluating its MagicTouch™ sirolimus-coated balloon (SCB) for the treatment of small coronary vessels. This first U.S. enrollment follows the FDA's IDE approval of MagicTouch SCB, marking a major milestone in Concept Medical's mission to revolutionize coronary artery disease (CAD) treatment and expand its clinical program into the US and Europe. Dr. Samin Sharma enrolled the first patient at New York's Mount Sinai Hospital, Director of Interventional Cardiology, marking a crucial step in advancing treatment options for patients with small-vessel coronary artery disease. 'Today marks a great feat for us and for the MAGICAL-SV trial,' said Dr. Samin Sharma. 'My team at Mount Sinai is privileged to be the first to begin this study. This is a proud moment for all of us, especially knowing what the trial signifies and aims to achieve by evaluating MagicTouch as a potential alternative for treating small vessels in the U.S.' Concept Medical is now actively enrolling in three IDE trials concurrently in the U.S., across coronary and peripheral interventions, underscoring its commitment to bringing innovative therapies to patients worldwide. MAGICAL-SV is a prospective, multicenter, single-blind randomized trial (2:1 randomization) comparing Concept Medical's MagicTouch sirolimus-coated balloon to DES (Everolimus eluting stents [EES] or Zotarolimus eluting stents [ZES]) for the treatment of small coronary artery lesions. Randomization is stratified by study site and presence of medically-treated diabetes mellitus status. The trial will enroll 1,605 patients across the U.S. and Europe, to evaluate the primary endpoint of target lesion failure (TLF) at 12 months. An international team of renowned cardiologists, Dr. Martin B. Leon (USA) – Study Chair, with principal investigators (PI) Dr. Azeem Latib (USA), Dr. Ajay Kirtane (USA), and Prof. Antonio Colombo (Europe) will lead the MAGICAL-SV trial. Dr. Azeem Latib, a U.S. PI for MAGICAL-SV, noted, 'The first U.S. patient enrollment in the MAGICAL-SV study marks an exciting step forward in building robust evidence for SCB technology in the treatment of small-vessel coronary disease. As we explore metal-free PCI strategies, this study brings renewed hope for safer, more effective options for our patients.' Prof. Antonio Colombo, who leads the European arm, added, 'Starting small and going big! MAGICAL-SV represents an important step in building evidence for sirolimus-coated balloons.' This milestone embodies a 'leave nothing behind' philosophy in coronary interventions, treating arterial blockages without permanent implants and addressing the limitations of metallic stents in small vessels. Dr. Martin B. Leon, the Study Chair, emphasized evaluating a no-stent strategy through this trial: 'The initiation of the MAGICAL-SV trial marks an important step in evaluating sirolimus-coated balloon therapy for small coronary vessels. By addressing key limitations of stenting in this complex anatomy, the study aims to generate strong comparative data versus DES. The results could inform future treatment strategies in the U.S. and Europe, offering clinicians a potential alternative for managing small-vessel disease.' The pioneering MAGICAL-SV trial aims to yield strong clinical evidence for sirolimus-coated balloon therapy, supporting Pre-Market Approval (PMA) for MagicTouch SCB in small vessels and potentially redefining CAD treatment. Dr. Manish Doshi, Founder and MD of Concept Medical, said, "MAGICAL-SV marks another step in our mission to redefine vascular care. We're focused on delivering next-generation solutions, helping clinicians achieve better outcomes and give CAD patients a better quality of life." For media inquiries contact: [email protected] Disclaimer: The above press release comes to you under an arrangement with Business Wire India. Business Upturn take no editorial responsibility for the same. Ahmedabad Plane Crash
Business Wire
6 days ago
- Business
- Business Wire
Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe
BUSINESS WIRE)-- Concept Medical Inc., a global pioneer in drug-delivery technologies, announced the enrollment of the first patient in the MAGICAL-SV (MAGI cTouch™ Sirolimus-Coated Balloon for Treatment of C oronary A rtery L esions in S mall V essels) trial, a U.S. Investigational Device Exemption (IDE) study evaluating its MagicTouch™ sirolimus-coated balloon (SCB) for the treatment of small coronary vessels. This first U.S. enrollment follows the FDA's IDE approval of MagicTouch SCB, marking a major milestone in Concept Medical's mission to revolutionize coronary artery disease (CAD) treatment and expand its clinical program into the US and Europe. Dr. Samin Sharma enrolled the first patient at New York's Mount Sinai Hospital, Director of Interventional Cardiology, marking a crucial step in advancing treatment options for patients with small-vessel coronary artery disease. 'Today marks a great feat for us and for the MAGICAL-SV trial,' said Dr. Samin Sharma. 'My team at Mount Sinai is privileged to be the first to begin this study. This is a proud moment for all of us, especially knowing what the trial signifies and aims to achieve by evaluating MagicTouch as a potential alternative for treating small vessels in the U.S.' Concept Medical is now actively enrolling in three IDE trials concurrently in the U.S., across coronary and peripheral interventions, underscoring its commitment to bringing innovative therapies to patients worldwide. MAGICAL-SV is a prospective, multicenter, single-blind randomized trial (2:1 randomization) comparing Concept Medical's MagicTouch sirolimus-coated balloon to DES (Everolimus eluting stents [EES] or Zotarolimus eluting stents [ZES]) for the treatment of small coronary artery lesions. Randomization is stratified by study site and presence of medically-treated diabetes mellitus status. The trial will enroll 1,605 patients across the U.S. and Europe, to evaluate the primary endpoint of target lesion failure (TLF) at 12 months. An international team of renowned cardiologists, Dr. Martin B. Leon (USA) - Study Chair, with principal investigators (PI) Dr. Azeem Latib (USA), Dr. Ajay Kirtane (USA), and Prof. Antonio Colombo (Europe) will lead the MAGICAL-SV trial. Dr. Azeem Latib, a U.S. PI for MAGICAL-SV, noted, 'The first U.S. patient enrollment in the MAGICAL-SV study marks an exciting step forward in building robust evidence for SCB technology in the treatment of small-vessel coronary disease. As we explore metal-free PCI strategies, this study brings renewed hope for safer, more effective options for our patients.' Prof. Antonio Colombo, who leads the European arm, added, 'Starting small and going big! MAGICAL-SV represents an important step in building evidence for sirolimus-coated balloons.' This milestone embodies a 'leave nothing behind' philosophy in coronary interventions, treating arterial blockages without permanent implants and addressing the limitations of metallic stents in small vessels. Dr. Martin B. Leon, the Study Chair, emphasized evaluating a no-stent strategy through this trial: 'The initiation of the MAGICAL-SV trial marks an important step in evaluating sirolimus-coated balloon therapy for small coronary vessels. By addressing key limitations of stenting in this complex anatomy, the study aims to generate strong comparative data versus DES. The results could inform future treatment strategies in the U.S. and Europe, offering clinicians a potential alternative for managing small-vessel disease.' The pioneering MAGICAL-SV trial aims to yield strong clinical evidence for sirolimus-coated balloon therapy, supporting Pre-Market Approval (PMA) for MagicTouch SCB in small vessels and potentially redefining CAD treatment. Dr. Manish Doshi, Founder and MD of Concept Medical, said, "MAGICAL-SV marks another step in our mission to redefine vascular care. We're focused on delivering next-generation solutions, helping clinicians achieve better outcomes and give CAD patients a better quality of life."
Time of India
03-08-2025
- General
- Time of India
Residents raise safety concerns as stray dog population rises in Vasavi Nagar
1 2 Hyderabad: Residents of Vasavi Nagar colony in Secunderabad Cantonment Board (SCB) are at their wits' end over the stray dog menace in their area, which has reportedly risen to worrying proportions over the last several years. Once numbering just a handful, the colony has over 50 stray dogs now. "I am deeply empathetic towards stray dogs. However, their numbers are rising uncontrollably, posing a real risk to residents, particularly children. One stray dog living in my street gave birth to 18 puppies over the last three years. My husband was bitten by a dog a month ago," said Saritha Chitha, a resident who works for a US consultancy. "I don't want the dogs to be removed, but neutering them is absolutely necessary," she said. You Can Also Check: Hyderabad AQI | Weather in Hyderabad | Bank Holidays in Hyderabad | Public Holidays in Hyderabad Ravinder Chadha, an IT professional and a resident of the colony, said people have stopped stepping out of their houses because of the stray dog menace. "During the nights, the dogs become erratic and gang up on anybody who steps out of the house, making it unsafe for us, especially senior citizens. Moreover, they keep barking in the night, disturbing our sleep," he said, adding that the stray dogs chase and hassle delivery partners and visitors to the colony. "There are some residents who feed the dogs, because of which more dogs keep coming to the colony. I request these residents to stop feeding them. I also request Blue Cross, which has rescued and nurtured stray dogs from many places across the city, to also adopt the dogs from our colony. Residents won't be bothered anymore and the dogs will be taken care of too," said Telukunta Satish Gupta, a resident. Govt officials said that while they have been actively taking steps to vaccinate stray dogs and execute animal birth control (ABC) programmes, relocating them would be a violation of the law. "We have sterilised over 80% of the stray dogs in the city, and we have been quick to address complaints too. As per the ABC (Dogs) Rules 2001, we have to release the dogs after sterilisation back to where we took them from. So, if residents are demanding for the stray dogs to be relocated to another area, it's simply not possible," said Abdul Wakeel, chief veterinary officer (CVO) of the Greater Hyderabad Municipal Corporation (GHMC). Get the latest lifestyle updates on Times of India, along with Friendship Day wishes , messages and quotes !
Time of India
03-08-2025
- Health
- Time of India
HC directs state govt to take steps to resume liver transplants in SCB
Cuttack: Orissa high court has directed the state govt to take urgent steps to resume liver transplant surgeries at SCB Medical College and Hospital (SCBMCH), Cuttack. The surgeries have been halted since April following the expiry of an MoU with a Hyderabad-based institute. Tired of too many ads? go ad free now In an order on July 31, the division bench comprising Justices S K Sahoo and V Narasingh said liver transplants are "crucial and cannot be deferred indefinitely". It directed the govt to provide a timeline for approval of a new partnership and resumption of transplants. The court was hearing a matter related to the discontinuation of transplants at SCB. Additional director of medical education and training and nodal officer for organ transplant, Dr Umakant Satapathy, informed the court via video link that a proposal for an MoU with MGM Healthcare, Chennai, for 30 liver transplants is pending with the govt. Taking note of the submission, the court asked the state to explore continuing the earlier arrangement with the Asian Institute of Gastroenterology (AIG), Hyderabad, to avoid any disruption in patient care. The bench directed the govt to file an affidavit by Tuesday, detailing how many patients are currently awaiting liver transplants, how many applications have been disposed of in the past three months, and minutes of SCB's authorisation committee meetings over the past six months. The next hearing is scheduled for Aug 7. On July 18, the HC had taken suo motu cognisance of a report published in a vernacular daily stating that liver transplants at SCB had come to a halt after the agreement with AIG expired on April 1. State govt had signed the MoU in 2022 to operationalise a liver transplant unit, which was officially launched in 2023 with Rs 22 crore sanctioned for infrastructure and logistics. Only two transplants have been conducted under the programme so far — the first on April 3, 2024, and the second on Sept 9, 2024. The initiative was designed to offer the high-cost procedure free of charge to eligible patients. With SCB lacking a fully trained in-house transplant team, the continuation of the programme remains uncertain unless a new partnership is secured soon.
Time of India
02-08-2025
- Health
- Time of India
HC seeks fresh report on condition of SCB's central kitchen
1 2 Cuttack: Orissa high court has asked the advocates' committee of the High Court Bar Association to revisit the central kitchen of SCB Medical College and Hospital, Cuttack and submit a fresh report, following allegations of preparation of food under unhygienic conditions for patients. The court was hearing the matter based on a report submitted by the committee on Thursday. The report, based on an inspection on June 30, highlighted serious health concerns, including non-functional roti-making machines and unsanitary conditions posing risk to patient health. The court was shown video footage that revealed lapses like kitchen staff collecting rotis without gloves, many without head and mouth covers, and personnel wearing shoes being allowed inside the kitchen area. Taking on record an affidavit filed by the SCB superintendent, the division bench comprising Justices S K Sahoo and V Narasingh asked the committee to submit a fresh report. The matter is scheduled for further hearing on Sept 11. In his affidavit filed on July 29, SCB superintendent Dr Goutam Kumar Satapathy stated that the hospital has 2,772 functional beds. However, a surplus number of patients are being admitted and accommodated beside the beds and are being provided with medical services and food. Indoor patients are being provided with cooked and dry diet thrice a day as per the requirement received from different wards and departments. Satapathy acknowledged the issues raised in the report and stated that food services had been outsourced to a Berhampur-based agency in line with National Health Mission (NHM) guidelines. The agency has been given space, power, and water to operate on the hospital premises. He informed the court that mechanical roti preparation had resumed on July 21 using new machines with conveyor belt roasting. Civil and electrical renovation work in the kitchen, undertaken by the roads and buildings department, is expected to be completed by the end of Aug. Rodent control measures will follow. A meeting of the hospital's diet vigilance committee was held on July 4, where steps to improve kitchen hygiene and efficiency were discussed. The hospital superintendent assured the court that strict hygiene protocols would be enforced. Get the latest lifestyle updates on Times of India, along with Friendship Day wishes , messages and quotes !
