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16:03 EDT Abbott presents data on minimally invasive structural heart technologies - Abbott announced data from five late-breaking presentations showing the benefits of its minimally invasive devices in treating people with a range of structural heart diseases. Data include findings that reinforce the value of MitraClip, the world's first and leading transcatheter edge-to-edge repair device, to treat leaky valves in people with mitral regurgitation. The new data around Abbott's structural heart therapies were presented at the 34th Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation in Boston. Results were also presented on TriClip, the first therapy designed specifically for tricuspid heart valve repair; the Amplatzer Amulet Left Atrial Appendage Occluder, a minimally invasive option offering the most complete closure of the left atrial appendage to reduce risk of stroke; and Portico, a self-expanding transcatheter aortic valve implantation system. Structural heart diseases such as valve disease or openings in the heart that require closure can impair how the heart moves blood through the body. New minimally invasive technology has changed how physicians approach patient care and limits the need for more complex or risky surgery. Data presented from the prospective, multi-center, global real-world EXPAND G4 study support the safety and effectiveness of the MitraClip G4 system for treating MR. The study represents the largest report of 30-day core lab-assessed outcomes, which included more than 1,000 patients. The data confirm that MitraClip offers high success rates in terms of MR reduction, improvements in quality of life and low adverse event rates. Key findings through 30 days include: Significant MR reduction to mild or less is achieved in 91% of patients, with lowest reported adverse event rates to date; Clinical improvements including 83% of patients achieving New York Heart Association Functional Class I/II, an improvement of 52% from baseline of 31%; and an 18-point improvement in the Kansas City Cardiomyopathy Questionnaire score, a 35% improvement from baseline score; Multiple clip sizes enable tailoring the therapy to patients' mitral valve anatomy and expand the spectrum of TEER-suitable patients. TRILUMINATE Pivotal is the first randomized, controlled clinical trial evaluating the safety and effectiveness of TEER with TriClip in 700 patients with severe TR in the U.S., Canada and Europe. The data from the roll-in cohort through 30 days show: High implant success rate; At least a one-grade TR reduction in 91% of patients, with moderate or less residual TR achieved in 74%; Patients achieving around a 17-point improvement in the KCCQ score, a 30% improvement from baseline score, which demonstrates a substantial improvement in their quality of life; The Amplatzer Amulet LAA Occluder with dual-seal technology is the first and only minimally invasive treatment option to offer immediate and complete dual-sealing closure of the LAA, reducing the risk of stroke and eliminating the need for blood-thinning medication. The prospective, international, multi-center Amulet IDE trial is the largest randomized LAA occlusion study to date consisting of more than 1,800 patients, and three-year outcomes demonstrate the safety and effectiveness of Amulet, with data showing: Device-related factors more frequently preceded strokes in patients with Boston Scientific's Watchman than those with Amulet; Both cardiovascular and all-cause death trended higher in the Watchman device than the Amulet device PREDICT-LAA Trial. Data were also presented from the PREDICT-LAA prospective, multi-center, randomized controlled trial that studied if the use of cardiac computed tomography-based computational models help in the planning of Amplatzer Amulet procedures. Key findings at three months include: Improved procedural efficiency and safety outcomes with the Amplatzer Amulet LAA Occluder were achieved when planned with HEARTguide. The CONFIDENCE Registry is an international, prospective, real-world study evaluating the safety and effectiveness of the Portico TAVI valve using the first-generation Portico delivery system in 501 patients and the second-generation FlexNav delivery system in 500 patients.

15:53 EDT Bluebird receives FDA accelerated approval for SKYSONA for early, active CALD - Bluebird Bio announced the U.S. Food and Drug Administration has granted Accelerated Approval of SKYSONA, also known as eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy. The company also confirmed that the previous clinical hold on the eli-cel clinical development program has been lifted. CALD is a rare, progressive, neurodegenerative disease that primarily affects young boys and causes irreversible, devastating neurologic decline, including major functional disabilities such as loss of communication, cortical blindness, requirement for tube feeding, total incontinence, wheelchair dependence, or complete loss of voluntary movement. Nearly half of patients who do not receive treatment die within five years of symptom onset. Prior to the approval of SKYSONA treatment, effective options were limited to allogeneic hematopoietic stem cell transplant, which is associated with the risk of serious potential complications including death, that can increase dramatically in patients without a human leukocyte antigen matched donor. As a condition of the SKYSONA Accelerated Approval, bluebird has agreed to provide confirmatory long-term clinical data to the FDA. bluebird anticipates that this will include data from the ongoing long-term follow-up study, which follows patients treated in clinical trials for 15 years, and from commercially treated patients. Bluebird anticipates that commercial product will be available by the end of 2022 through a limited number of Qualified Treatment Centers in the United States, including Boston Children's Hospital and Children's Hospital of Philadelphia. Bluebird has set the wholesale acquisition cost of SKYSONA in the U.S. at $3.0M. The SKYSONA Biologics License Application was reviewed by the U.S. FDA under Priority Review, and bluebird received a rare pediatric priority review voucher upon approval. SKYSONA was previously granted Orphan Drug designation, Rare Pediatric Disease designation, and Breakthrough Therapy designation.