Dive Brief The Centers for Medicare and Medicaid Services shared a pair of proposed rules on Thursday afternoon that set rates for physician payments and outpatient procedures. The agency issued the 2024 Hospital Outpatient Prospective Payment System and 2024 Physician Fee Schedule proposed rules, both of which are expected to be finalized this fall. Glaukos could be the biggest beneficiary of the proposals among device makers, with an increase in outpatient facility fee rates likely to provide a “meaningful boost” for its iStent device to treat patients with glaucoma, BTIG analyst Ryan Zimmerman wrote in a research note on Thursday. Dive Insight The two payment proposals include reimbursement increases for some medical device companies, and cuts for others. San Clemente, Calif.-based ophthalmic device company Glaukos is among those who stand to benefit. Its ambulatory surgical center facility fee for the iStent infinite device was nearly doubled ...
A new research perspective was published in Oncoscience (Volume 10) on May 27, 2023, entitled, “Think outside the box – atypical infections in chronic sinusitis.” Inflammations of the paranasal sinuses represent a common clinical picture. The annual prevalence of chronic sinusitis in Europe is up to 10%. Sinusitis can be divided into acute and chronic forms. In particular, the chronic forms (>12 weeks duration) are often challenging in the context of therapy. Generally, all ventilation disorders of the paranasal sinuses (concha bullosa, nasal septal deviations, etc.,) represent risk factors for the development of any form of sinusitis. In addition, an immune deficiency or systemic diseases relevant to the immune system predispose to infections with atypical pathogens. Most sinusitis are caused by viruses, sometimes bacteria and, in rare cases, fungal infections. Furthermore, sinusitis can be differentiated with regard to the affected paranasal sinuses. In addition to conservative ...
Dive Brief The U.S. Food and Drug Administration has approved Urotronic’s minimally invasive surgical treatment of symptoms linked to benign prostatic hyperplasia (BPH), the company announced Tuesday. BPH is defined by the expansion of the prostate. As the organ grows, it can cause changes in the bladder that result in lower urinary tract symptoms such as leaking urine. Urotronic’s newly approved Optilume BPH catheter system is designed to tackle the symptoms through mechanical dilation and the delivery of paclitaxel to stop the problem from recurring. Dive Insight Researchers studied the use of balloon dilation in BPH in the 1990s, but the technique failed to provide long-term benefits. Urotronic has tried to address that problem by pairing the immediate symptomatic relief provided by balloon dilation with localized delivery of paclitaxel, a drug that is already widely used in cardiovascular devices to prevent blood vessels from narrowing after ...
PrecisionLife, a leading techbio company driving precision medicine in complex chronic diseases, announced today a data access agreement with the University of Oxford to license the Oxford Endometriosis Gene (OXEGENE) dataset with the aim to develop new personalized treatments for endometriosis patients. Endometriosis is a chronic disease associated with severe pain and infertility. It affects 10% of women globally, but how and why it develops is unknown. On average it takes over 7 years for patients to receive a diagnosis and there are currently no approved diagnostic biomarkers or cures for the disease. The OXEGENE dataset contains anonymized genotype data including disease stage and infertility status, from 1,000 surgically confirmed patients. PrecisionLife’s combinatorial analytics platform is unique in its ability to analyze patient data to better understand the causes of complex chronic disease and achieve mechanistic patient stratification to enable precision medicine where it has not previously been ...
Patients undergoing bilateral total knee arthroplasty (TKA) are at an increased risk of several types of complications, as compared with matched patients undergoing unilateral TKA, reports a study in The Journal of Bone & Joint Surgery. The journal is published in the Lippincott portfolio in partnership with Wolters Kluwer. “Patients who underwent simultaneous bilateral TKA were at higher risk of experiencing postoperative complications such as pulmonary embolism, stroke, blood loss anemia, and requiring a transfusion,” according to the report by Nathanael D. Heckmann, MD, and colleagues of Keck School of Medicine of USC, Los Angeles. Study in matched groups of patients clarifies risks of bilateral TKA TKA is a highly effective treatment for patients with advanced osteoarthritis of the knee, decreasing pain and improving function. When both knees are affected, bilateral TKA offers some advantages over sequential unilateral TKA, including less time in the hospital, a single rehabilitation period, and ...
GLORIA trial shows increased survival levels among newly diagnosed brain cancer patients TME Pharma – a company concentrating on the development of therapies for treating cancer – has announced a positive update on the survival of first-line glioblastoma patients taking part in the company’s GLORIA trial. Across the wider GLORIA clinical trial, TME is researching the effectiveness of NOX-A12 among newly-diagnosed brain cancer patients who will not benefit from standard chemotherapy. Meanwhile, the expanded arm of the study is focusing on the candidate – a CXCL12 inhibitor – in combination with standard of care radiotherapy and bevacizumab. Following 15 months of the research, 83% of trial patients (five out of six) were still alive. Furthermore, as long as treatment or follow-ups for these patients continues, median overall survival will improve. The expected median overall survival for patients under existing standard of care, with chemotherapy refractory tumours – and whose tumour ...
Dive Brief Intuitive Surgical’s minimally invasive bronchoscopy platform Ion may provide “some of the most exciting advancements in robotic technology” in the coming years, according to analysts at BTIG. While Ion contributed an estimated $115 million of the company’s $6.2 billion in revenue last year, the analysts see scope for Intuitive to grow sales by capturing more of the lung biopsy market and expanding into the ablation of tumors. Intuitive competes for the bronchoscopy market with Johnson & Johnson’s Monarch platform. The analysts estimate there are about twice as many Ion systems as Monarch devices in use. Dive Insight Intuitive’s success rests on its da Vinci robotic platform and discussions of the future of the company focus on whether J&J and Medtronic can challenge the dominance of that device, the BTIG analysts said. “Intuitive’s push into robotic bronchoscopy is purposeful, not just simply for the bronchoscopy opportunity, but for its ...
The FDA will release its verdict on June 16 regarding Bristol Myers Squibb‘s sNDA proposing to use its heart drug Camzyos (mavacamten) to lower the need for septal reduction therapy (SRT) in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Currently, many patients suffering from HCM need to undergo SRT, Roland Chen, senior vice president and head of cardiovascular development, Global Drug Development at BMS, said in a statement upon the FDA’s acceptance of the sNDA. SRT is either an open-heart surgical procedure or a catheter-based operation. BMS supported Camzyos’ sNDA with data from the Phase III VALOR-HCM study, a randomized, double-blinded and placebo-controlled trial that enrolled 112 patients with symptomatic obstructive HCM. All participants were qualified for SRT and had been referred for the operation. VALOR-HCM’s primary endpoint was a composite between the number of patients who decided to push through with SRT by week 16 and the number of ...
Moderna and Merck’s experimental cancer vaccine, used in combination with Merck’s Keytruda, reduced the risk of the most deadly form of skin cancer spreading to other parts of the body in a clinical trial, according to the midstage trial results published Monday. Moderna and Merck’s cancer vaccine reduced the risk of melanoma spreading to other parts of the body or death by 65% in patients with stage 3 or 4 of the disease compared with patients who received Merck’s immunotherapy treatment alone, the trial has found. Moderna and Merck will present the data at the American Society of Clinical Oncology’s annual conference in Chicago at 5 p.m. ET. The clinical trial has enrolled 157 patients who have had their cancer surgically removed. Patients in the treatment group receive 1 milligram injections of the vaccine every three weeks for nine total doses and 200 mg intravenous infusions of Keytruda every three ...
Survival rate beyond 10 years in children with drug-resistant epilepsy (DRE) was highest after cranial epilepsy surgery and lowest when treated only with antiseizure medications, according to a study published in The Lancet Child and Adolescent Health. This large, retrospective study was the first to compare long-term survival in children with DRE among cohorts treated with medications only, vagus nerve stimulation plus medications, and cranial epilepsy surgery plus medications. Results show that risk of early death was reduced by over 80% after surgery and by 40% after vagus nerve stimulation, compared to medication-only treatment. People with epilepsy have increased mortality rates compared to the age-matched population. Epilepsy is one of the most common neurological conditions, affecting at least 3.4 million people in the United States. Among children with epilepsy, an estimated 20% have DRE. “We provide critical evidence for healthcare decision making for pediatric patients with drug-resistant epilepsy,” said senior ...
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