Texas Cardiac Arrhythmia Institute at St. David's Medical Center first in U.S. to use FDA-approved novel wireless system to treat cardiac arrhythmias Français
"This technology marks a significant advancement in how we care for patients with heart rhythm disorders—particularly those who previously had few viable cardiac resynchronization therapy treatment options," said Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., cardiac electrophysiologist and executive medical director of TCAI. "At the Texas Cardiac Arrhythmia Institute, our commitment is to bring the most advanced, evidence-based therapies to patients worldwide, and as a result of Dr. Canby's leadership, we successfully delivered on that promise."
The system is the first-ever to stimulate the heart muscle electrically via a small, leadless device—about the size of a grain of rice—that is implanted inside tissue of the left ventricle, the heart's primary pumping chamber. The device converts ultrasound energy into electrical pulses, restoring the heart's normal rhythm and pumping efficiency.
Traditional cardiac resynchronization therapies involve leads—thin and soft insulated wires about the size of a spaghetti noodle. This left ventricular endocardial pacing device provides a direct approach, which enables more flexible placement and expands access to those who were previously considered untreatable.
TCAI is a state-of-the-art Electrophysiology Center that includes six labs equipped with advanced technology where a group of esteemed cardiac electrophysiologists—led by Dr. Natale, a world-renowned expert in the field—perform a high volume of the most complex electrophysiology procedures.
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As reported yesterday by Naomi Kresge at Bloomberg News: Roche Holding AG says the recent death of a patient in Brazil who had been treated with gene therapy Elevidys for Duchenne muscular dystrophy is unrelated to the treatment. * The boy wasn't a clinical trial participant; reporting physician assessed his death as being unrelated to the gene therapy, Roche says in statement * Death was reported to health authorities * Roche, which markets Sarepta's Duchenne treatment Elevidys outside the US, declines to comment on the boy's age or details of the case Sarepta reported this event to FDA on June 18, 2025, via the FDA's postmarketing electronic database, FAERS. At Sarepta, patient safety and well-being are always our top priority. We are committed to upholding the highest safety standards for all of our therapies, and do so in accordance with applicable law and commitment to full regulatory transparency. ELEVIDYS is the only approved gene therapy for families and children devastated by Duchenne, a rare, progressive and ultimately fatal disease. We remain committed to working closely with the FDA to ensure that all decisions are grounded in science and the best interests of patients, considering the compelling need of these families to access disease-modifying therapy. About ELEVIDYS (delandistrogene moxeparvovec-rokl) ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. 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Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials and ELEVIDYS. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading 'Risk Factors' in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law. Source: Sarepta Therapeutics, Inc.
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2 days ago
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Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve. Media Contact Company Name: DelveInsight Contact Person: Jatin Vimal Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
Cision Canada
2 days ago
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