The estimated fair value of the consideration transferred to acquire NeoTract was $975.2 million, which included initial payments of $725.6 million in cash less a favorable working capital adjustment of $1.4 million (for which we had not yet received payment as of December 31, 2017) and $251.0 million in estimated fair value of contingent consideration. ("NeoTract"), a medical device company that has developed and commercialized the UroLift System, a minimally invasive medical device for treating lower urinary tract symptoms due to benign prostatic hyperplasia, or BPH. On October 2, 2017, we acquired NeoTract, Inc. We believe that 510(k) clearance or 510(k)-exempt status reduces our research and development costs and risks, and typically results in a shorter timetable for new product introductions as compared to the premarket approval, or PMA, process that would be required for Class III devices. Our portfolio of existing products and products under development consists primarily of Class I and Class II devices, most of which require 510(k) clearance by the United States Food and Drug Administration ("FDA"), for sale in the United States, and some of which are exempt from the requirement to obtain 510(k) clearance. During 2017 we introduced several product line extensions and 10 new products. Our research and development initiatives focus on developing these products for both existing and new therapeutic applications, as well as enhancements to, and product line extensions of, existing products. Then release the clamp to relieve the negative pressure.Our research and development capabilities, commitment to engineering excellence and focus on low-cost manufacturing enable us to bring cost effective, innovative products to market that improve the safety, efficacy and quality of healthcare. If you do not use a stopcock, you can aspirate the catheter, then clamp it while you change syringes. So simply placing a syringe filled with the clearing agent on the catheter hub and injecting the agent could lead to this excessive force. When you turn the stopcock to the syringe with the clearning agent, the release of the negative pressure facilitates the injection of the agent.Įxcessive force on any occluded catheter can easily lead to the occluding material being forced from the catheter lumen, rupture of the catheter wall, or both. The stopcock method allows for easy withdrawal of this fluid and maintains this negative pressure on the catheter. There could easily be infused fluid between this material and the catheter hub.
The problem with instilling any catheter with any clearing agent (thrombolytic, alkalizing or acidifying agent, etc) would be actually getting the agent to the location of the occluding material (clot or drug precipitate). PICCs usually do not have this problem because the tip is in the SVC with much greater blood flow. Midline catheters can be associated with serious chemical phlebitis at the catheter tip because they are still in a peripheral vein.
As with any catheter, you need a thorough assessment to make a good decision about what is causing the problem. If your assessment leads you to believe that a midline catheter has an intraluminal clot, then it would be appropriate to use a thrombolytic agent to declot.
0 kommentar(er)
