TAMPA, Fla.--(BUSINESS WIRE)--Aug 4, 2025--
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.
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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 SCBtechnologyin 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."
Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Study
WASHINGTON (AP) — Most American presidents aspire to the kind of greatness that prompts future generations to name important things in their honor.
Donald Trump isn't leaving it to future generations.
As the first year of his second term wraps up, his administration and allies have put the president’s name on the U.S. Institute of Peace, the Kennedy Center performing arts venue and a new class of battleships.
That’s on top of the “Trump Accounts” for tax-deferred investments, the TrumpRx government website soon to offer direct sales of prescription drugs, the “Trump Gold Card” visa that costs at least $1 million and the Trump Route for International Peace and Prosperity, a transit corridor included in a deal his administration brokered between Armenia and Azerbaijan.
On Friday, he plans to attend a ceremony in Florida where local officials will dedicate a 4-mile (6-kilometer) stretch of road from the airport to his Mar-a-Lago estate as President Donald J. Trump Boulevard.
It’s unprecedented for a sitting president to embrace tributes of that number and scale, especially those proffered by members of his administration. And while past sitting presidents have typically been honored by local officials naming schools and roads after them, it's exceedingly rare for airports, federal buildings, warships or other government assets to be named for someone still in power.
“At no previous time in history have we consistently named things after a president who was still in office,” said Jeffrey Engel, the David Gergen Director of the Center for Presidential History at Southern Methodist University in Dallas. “One might even extend that to say a president who is still alive. Those kind of memorializations are supposed to be just that — memorials to the passing hero.”
White House spokeswoman Liz Huston said the TrumpRx website linked to the president's deals to lower the price of some prescription drugs, along with “overdue upgrades of national landmarks, lasting peace deals, and wealth-creation accounts for children are historic initiatives that would not have been possible without President Trump’s bold leadership.”
"The Administration’s focus isn’t on smart branding, but delivering on President Trump’s goal of Making America Great Again," Huston said.
The White House pointed out that the nation's capital was named after President George Washington and the Hoover Dam was named after President Herbert Hoover while each was serving as president.
For Trump, it’s a continuation of the way he first etched his place onto the American consciousness, becoming famous as a real estate developer who affixed his name in big gold letters on luxury buildings and hotels, a casino and assorted products like neckties, wine and steaks.
As he ran for president in 2024, the candidate rolled out Trump-branded business ventures for watches, fragrances, Bibles and sneakers — including golden high tops priced at $799. After taking office again last year, Trump's businesses launched a Trump Mobile phone company, with plans to unveil a gold-colored smartphone and a cryptocurrency memecoin named $TRUMP.
That’s not to be confused with plans for a physical, government-issued Trump coin that U.S. Treasurer Brandon Beach said the U.S. Mint is planning.
Trump has also reportedly told the owners of Washington’s NFL team that he would like his name on the Commanders’ new stadium. The team’s ownership group, which has the naming rights, has not commented on the idea. But a White House spokeswoman in November called the proposed name “beautiful” and said Trump made the rebuilding of the stadium possible.
The addition of Trump’s name to the Kennedy Center in December so outraged independent Sen. Bernie Sanders of Vermont that he introduced legislation this week to ban the naming or renaming of any federal building or land after a sitting president — a ban that would retroactively apply to the Kennedy Center and Institute of Peace.
“I think he is a narcissist who likes to see his name up there. If he owns a hotel, that’s his business,” Sanders said in an interview. “But he doesn’t own federal buildings.”
Sanders likened Trump's penchant for putting his name on government buildings and more to the actions of authoritarian leaders throughout history.
“If the American people want to name buildings after a president who is deceased, that’s fine. That’s what we do,” Sanders said. “But to use federal buildings to enhance your own position very much sounds like the ‘Great Leader’ mentality of North Korea, and that is not something that I think the American people want.”
Although some of the naming has been suggested by others, the president has made clear he’s pleased with the tributes.
Three months after the announcement of the Trump Route for International Peace and Prosperity, a name the White House says was proposed by Armenian officials, the president gushed about it at a White House dinner.
“It’s such a beautiful thing, they named it after me. I really appreciate it. It’s actually a big deal,” he told a group of Central Asian leaders.
Engel, the presidential historian, said the practice can send a signal to people "that the easiest way to get access and favor from the president is to play to his ego and give him something or name something after him.”
Some of the proposals for honoring Trump include legislation in Congress from New York Republican Rep. Claudia Tenney that would designate June 14 as “Trump’s Birthday and Flag Day," placing the president with the likes of Martin Luther King Jr., George Washington and Jesus Christ, whose birthdays are recognized as national holidays.
Florida Republican Rep. Greg Steube has introduced legislation that calls for the Washington-area rapid transit system, known as the Metro, to be renamed the “Trump Train.” North Carolina Republican Rep. Addison McDowell has introduced legislation to rename Washington Dulles International Airport as Donald J. Trump International Airport.
McDowell said it makes sense to give Dulles a new name since Trump has already announced plans to revamp the airport, which currently is a tribute to former Secretary of State John Foster Dulles.
The congressman said he wanted to honor Trump because he feels the president has been a champion for combating the scourge of fentanyl, a personal issue for McDowell after his brother’s overdose death. But he also cited Trump’s efforts to strike peace deals all over the world and called him “one of the most consequential presidents ever.”
“I think that’s somebody that deserves to be honored, whether they’re still the president or whether they’re not," he said.
More efforts are underway in Florida, Trump’s adopted home.
Republican state lawmaker Meg Weinberger said she is working on an effort to rename Palm Beach International Airport as Donald J. Trump International Airport, a potential point of confusion with the Dulles effort.
The road that the president will see christened Friday is not the first Florida asphalt to herald Trump upon his return to the White House.
In the south Florida city of Hialeah, officials in December 2024 renamed a street there as President Donald J. Trump Avenue.
Trump, speaking at a Miami business conference the next month, called it a “great honor” and said he loved the mayor for it.
“Anybody that names a boulevard after me, I like,” he said.
He added a few moments later: “A lot of people come back from Hialeah, they say, ‘They just named a road after you.' I say, ‘That’s OK.’ It’s a beginning, right? It’s a start.”
FILE - A sign for the Rose Garden is seen near the Presidential Walk of Fame on the Colonnade at the White House, Jan. 13, 2026, in Washington. (AP Photo/Mark Schiefelbein, File)
FILE - President Donald Trump speaks with reporters as a flag pole is installed on the South Lawn of the White House, June 18, 2025, in Washington. (AP Photo/Evan Vucci, File)
FILE - Workers add President Donald Trump's name to the John F. Kennedy Memorial Center for the Performing Arts, after a Trump-appointed board voted to rename the institution, in Washington, Dec. 19, 2025. (AP Photo/J. Scott Applewhite, File)
FILE - A poster showing the Trump Gold Card is seen as President Donald Trump signs executive orders in the Oval Office of the White House, Sept. 19, 2025, in Washington. (AP Photo/Alex Brandon, file)
