PINNACLE

Elixir Medical To Announce Data from Three Platforms Designed to Transform Cardiovascular Disease Treatment at EuroPCR 2024, Including Two Late-Breakers

Retrieved on: 
Tuesday, April 30, 2024
Research, Medical Devices, Clinical Trials, Health Technology, Cardiology, Biotechnology, Health, General Health, Science, Elixir, Hospital, Coronary artery disease, Safety, PINNACLE, Catheterization laboratory, MD, Trial of the century, Doctor of Philosophy, PCI, TRX, OCT, CAD, Medicine, DES, Standard of care, Paulo, RCT, Plaque, MACE, Skåne University Hospital, Catheter, Pharmaceutical industry

“There remains a large unmet need for transformative technology in cardiovascular intervention to address limitations of coronary artery disease (CAD) treatments such as maintaining the established artery flow lumen, restoring vessel hemodynamic modulation, and stabilizing or regressing plaque to deliver durable and incremental clinical benefit.

Key Points: 
  • “There remains a large unmet need for transformative technology in cardiovascular intervention to address limitations of coronary artery disease (CAD) treatments such as maintaining the established artery flow lumen, restoring vessel hemodynamic modulation, and stabilizing or regressing plaque to deliver durable and incremental clinical benefit.
  • In the absence of restoring artery function, today we see 20% MACE within 5 years1 and 50% by 10 years2 after PCI attributable to non-plateauing annual adverse events with DES,”3 said Motasim Sirhan, CEO of Elixir Medical.
  • Featured as an Innovation Session presentation, the clinical results are intended to demonstrate safety and efficacy of Elixir’s lithotripsy technology designed to simplify treatment of a broad range of complex calcified lesions while advancing safety and efficacy of calcium modification.
  • Additionally, Elixir Medical will share late-breaking 12-month outcomes of its TRx site-specific antithrombotic therapeutic from the DESyne BDS Plus RCT, a prospective, multicenter, single-blind study evaluating the safety, effectiveness, and performance of the world’s first triple-drug site-specific antithrombotic therapy (TRx) on a DES compared to DESyne X2 Drug-Eluting Coronary Stent System in the treatment of de novo native coronary artery lesions.

Urotronic Announces FDA Approval of Optilume® BPH Catheter System, Pioneering the Next Generation of Minimally Invasive Solutions for Enlarged Prostate Symptom Relief

Retrieved on: 
Tuesday, July 11, 2023
Icahn School of Medicine at Mount Sinai, BPH, Food, Food and Drug Administration, LUTS, Paclitaxel, Quality of life, PINNACLE, Mount Sinai, MIST, Patient, FDA, Urology, Medical device, Medical imaging

Mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing.

Key Points: 
  • Mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing.
  • "With the highest reported Qmax in BPH MIST trials to date, Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies," said Dr. Steven A. Kaplan, professor of urology at the Icahn School of Medicine at Mount Sinai in New York.
  • Optilume BPH is a minimally invasive outpatient procedure engineered to alleviate urinary symptoms caused by BPH, a condition affecting 70% of men 60-69 years of age and 80% of those 70 or older.
  • By combining mechanical dilation with the safe and proven drug paclitaxel, the Optilume BPH Catheter System achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing.

Urotronic Announces Presentation of Data from Two Clinical Trials Evaluating Optilume® BPH System's Effectiveness and Durability

Retrieved on: 
Monday, May 1, 2023
Male, Icahn School of Medicine at Mount Sinai, BPH, Food, AUA, Urethral stricture, CE marking, LUTS, International Prostate Symptom Score, Paclitaxel, Quality of life, American Urological Association, PINNACLE, Food and Drug Administration, Mount Sinai, Sale, MIST, U.S. FDA, High, Lower urinary tract symptoms, Patient, Randomness, Trial of the century, FDA, Urology, IPSS, Medical imaging, Medical device, Pharmaceutical industry, Spirometry

MINNEAPOLIS, May 1, 2023 /PRNewswire/ -- Urotronic, Inc., a Minnesota-based medical device company pioneering the application of its drug-coated balloon technology for use in interventional urology, today announced the presentation of positive data from two clinical trials evaluating the Optilume® BPH System's effectiveness and durability in treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Four-year and 12-month data from the EVEREST and PINNACLE clinical trials were presented by Dr. Steven A. Kaplan, professor of urology at the Icahn School of Medicine at Mount Sinai in New York and the principal investigator of the two studies, during the American Urological Association's (AUA) Annual Meeting in Chicago.

Key Points: 
  • "The positive data from the PINNACLE and EVEREST trials – including the highest reported Qmax in BPH MIST trials to date – demonstrates clear and compelling sustained clinical outcomes through four years post-treatment," said Dr. Kaplan.
  • "Optilume BPH is not your grandfather's BPH balloon – it's the next generation of minimally invasive technology, creating a new drug device space among BPH therapies."
  • Mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing.
  • The highest average peak urinary flow rate (Qmax) at 12 months reported in randomized MIST trials for BPH.

Spectrum Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 11, 2022
Biotechnology, General Health, Health, Pharmaceutical, Oncology, FDA, ODAC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ESMO, U.S. Securities and Exchange Commission, PDUFA, ASCO, NDA, BID, American Society of Clinical Oncology, Spectrum Pharmaceuticals, Annual general meeting, SEC, Cancer, Clinical trial, SPPI, HER2, Research, Annual report, Biologics license application, Society, Security (finance), Neoplasm, NSCLC, Plasma, Patient, Review, DNA, 8-K, Continuous operation, Cohort, New Drug Application, Safety, PINNACLE, Circulating tumor DNA, Nasdaq, BLA, Webcast, Mutation, Medication, Private Securities Litigation Reform Act, Docetaxel, Fast Track, Total, Food, Fine chemical, Pharmaceutical industry, Spectrum

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today financial results for the three-month period ended June 30, 2022 and provided a corporate update.

Key Points: 
  • Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today financial results for the three-month period ended June 30, 2022 and provided a corporate update.
  • With this hurdle behind us, we have turned our focus to our potential approval and commercialization, said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals.
  • SPECTRUM PHARMACEUTICALS, INC. is a registered trademark of Spectrum Pharmaceuticals, Inc. and its affiliates.
  • REDEFINING CANCER CARE and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

Late-Breaking Study Results Reinforce Positive Real-World Outcomes with the WATCHMAN FLX™ LAAC Device

Retrieved on: 
Monday, February 28, 2022
Health, Ventricular fibrillation, Physician, BSX, PINNACLE, Risk, Intellectual property, Twitter, NCDR, Securities Exchange Act of 1934, LAAC, Boston, Security (finance), Annual report, NVAF, Stroke, Safety, NYSE, Arnold, U.S. Securities and Exchange Commission, Jorge Scientific Corporation, Pericardial effusion, Science, Intention, Boston Scientific, Life, CRT, Securities Act of 1933, Forward-looking statement, Patient, Technology, Drug Quality and Security Act, FLX, Incidence, Time, Medical device, Hospital, Pharmaceutical industry, Part Two, Facebook

MARLBOROUGH, Mass., Feb. 28, 2022 /PRNewswire/ --Boston Scientific Corporation (NYSE: BSX) today announced positive results from a new analysis assessing real-world outcomes with the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device.

Key Points: 
  • MARLBOROUGH, Mass., Feb. 28, 2022 /PRNewswire/ --Boston Scientific Corporation (NYSE: BSX) today announced positive results from a new analysis assessing real-world outcomes with the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device.
  • The positive data demonstrated a low 0.37% rate of major adverse events at seven days following a WATCHMAN FLX implant or the time of hospital discharge, whichever was later.
  • In the analysis, the WATCHMAN FLX device was successfully implanted in 97.6% of patients, and data also demonstrated low rates of ischemic stroke (0.28%) and device embolization (0.03%) in patients at 45 days.
  • The SURPASS study is ongoing and will continue to collect outcomes through at least two years post-implant on all patients in the NCDR-LAAO Registry treated with WATCHMAN FLX between August 2020 and August 2022.

Merck Announces Initiation of Phase 3 Study Evaluating VERQUVO® (vericiguat) in Patients with Chronic Heart Failure and Reduced Ejection Fraction Who Have Not Had a Recent Worsening Heart Failure Event

Retrieved on: 
Thursday, November 11, 2021
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, MSD, Population, Milk, Cancer, Heart failure, Clinical trial, Security (finance), Food, Bayer, COVID-19, Regulation of tobacco by the U.S. Food and Drug Administration, Department of Medicine – University of Pamplona, Heart, Hypotension, Life, Risk, Coronavirus, Pregnancy, University of Mississippi Medical Center, Blood, PINNACLE, Research, Diuretic, SGC, YouTube, Woman, Hospital, Tablet, Patent, Patient, Merck & Co., FDA, Chronic, Private Securities Litigation Reform Act, Medicine, Infection, Fetus, Animal, Anemia, Twitter, Vaccine, U.S. Securities and Exchange Commission, SEC, University, News, HF, HIV, MRK, Vericiguat, Instagram, Annual report, Birth, LinkedIn, NYSE, CVD, Pharmaceutical industry, Birth control, Heart Failure with Reduced Ejection Fraction, Merck, HEART FAILURE WITH REDUCED EJECTION FRACTION, MERCK

The primary efficacy endpoint is the time to first event of cardiovascular death or hospitalization for heart failure ( NCT05093933 ).

Key Points: 
  • The primary efficacy endpoint is the time to first event of cardiovascular death or hospitalization for heart failure ( NCT05093933 ).
  • The VERQUVO label contains a boxed warning that indicates that VERQUVO should not be administered to pregnant females because it may cause fetal harm.
  • Heart failure with reduced ejection fraction (HFrEF), formerly known as systolic heart failure, is characterized by the compromised ability of the heart to pump blood sufficiently during its contraction phase.
  • In the U.S., approximately 6.2 million adults (20 years of age and older) have heart failure, and approximately 50% of heart failure patients have HFrEF.