Implantable heart pumps supplier HeartWare International Inc (Nasdaq:HTWR)(ASX:HIN) reported on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for an IDE (Investigational Device Exemption) Supplement to start enrollment in an additional patient cohort
for the pivotal, Destination Therapy clinical study, ENDURANCE.
"It is encouraging that preliminary data with this sizeable patient cohort
in a real-world setting continue to demonstrate a strong safety profile and significant clinical efficacy for renal denervation with the Symplicity system, similar to what we've been seeing in the randomized, controlled clinical trial, Symplicity HTN-2," said Michael BE[micro]hm, MD, PhD, Chairman, Department of Internal Medicine, University of Srland, Homburg/Sr, Germany and Global SYMPLICITY Registry co-chair.
Consequently, recruitment of the second patient cohort
, who will be administered the drug at a higher pre-specified dose of RXC004, has begun as per the trial protocol.
The drug discovery and development company said recruitment of the second patient cohort
, who will be administered the drug at a higher pre-specified dose of RXC004, has begun.
"The big focus now is on expanding this patient cohort
. We want to move from anecdotal cases to a larger patient population with which we can statistically prove that we can nominate the best first-line therapy through this approach," he explained.
The abstract provided updated data from patient cohorts
1 through 3 of the study and new data from the ongoing patient cohort
4 in better vision patients.
As all of the above agents were commonly used in our patients' chemotherapy regimens, we also think that they significantly contributed to the findings in our patient cohort
. Overall, 25% of the subjects had a history of colorectal cancer in our group, and they all received systemic 5-FU and floxuridine as part of their treatment.
Furthermore, in a comparison of 64 inpatient and outpatient procedures, the total cost for the rare disease patient cohort
outweighed the costs of the comparative population in the majority of procedures.
Refluxate contaminating the extra-oesophageal tissues can be visualized and although 27% of patients showed evidence of pulmonary aspiration of refluxate, this may in fact be an underestimate of the true incidence of pulmonary aspiration in this type of patient cohort
. Patients are supine for approximately 30 minutes and are essentially upright for the other 90 minutes prior to the delayed scan for pulmonary aspiration.
An elastic net algorithm was used to create a predictive model of postoperative pain in the first 24 hours after surgery using a randomly selected training cohort; model performance was validated in an independent patient cohort
, and bootstrap modeling of factor selection was used to characterize its stability.
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. With Infor TrueCost, users can more accurately predict and track on-demand the expected cost of patients currently being treated and the cost impact of performance improvement initiatives and cost control measures."
Recently, we have demonstrated that PDE4D7 transcript levels correlate to the longitudinal outcome ofprostate cancer and independently add to postsurgical risk stratification in a consecutively operated prostate cancer patient cohort