Smiths Medical gets FDA clearance to market CADD-Solis system with PIB and PCA delivery in the US

Smiths Medical, a leading global medical device manufacturer, announced today it has received FDA 510(k) clearance to market its CADD^®-Solis pain management system version 3.0 with Programmed Intermittent Bolus (PIB) and Patient Controlled Analgesics (PCA) delivery in the United States. The new customizable, infusion system will help healthcare providers overcome challenges in maintaining effective epidural analgesia during labor and delivery or with post-operative pain management.

Epidural analgesia has traditionally been provided to patients using a pump that delivers manual bolus injections from a clinician, continuous infusions, or intermittent doses of medication controlled by the patient. All of these techniques can result in inconsistent and/or ineffective pain relief, as well as frequent clinician interventions.

PIB medication delivery, using the CADD^®-Solis v3.0 system, consistently administers programmed intermittent boluses that can be supplemented by patient-controlled doses.

"The new CADD^®-Solis system with PIB and PCA combines programmed intermittent boluses and patient-controlled doses in an integrated, innovative delivery system," said Tommy Johns, Vice President Global Product Management. "The PIB programming parameters and the delivery pressure provided by the CADD^®-Solis system offer flexible drug delivery and reliable distribution of medication, which can help overcome some of the challenges associated with epidural analgesia."

The CADD^®-Solis ambulatory infusion system is a state-of-the-art pain management system that meets industry recognized standards for advanced error-reduction features in PCA pumps. The CADD^®-Solis pump and medication safety software promotes patient safety, patient care, and future scalable connectivity that is designed to grow with evolving clinical and technology needs. The platform is designed for nurses, anesthesiologists, pharmacists and other hospital personnel involved in pain management infusion therapy who want the confidence of knowing they are delivering the highest level of patient care, with the most advanced combination of SMART medication delivery safety, mobility, versatility and reliability.

CADD^®-Solis Pain Management System Components:

CADD^®-Solis Ambulatory Infusion Pump -- a small, lightweight, versatile pump that promotes patient mobility and clinician convenience, and can be used for a variety of pain management therapies and patients. Its large color graphic display screen helps clinicians view and verify pump programs, identify and respond to alarms and interpret therapy trends and patient activity. The pump's task-based software and therapy-based drug protocol library is familiar to users, enhancing usability and safety. The scalable platform is designed to satisfy hospital's current and future clinical requirements and health information technology initiatives.

CADD^™-Solis Medication Safety Software - Administrator -- designed to help reduce the risk of medication delivery errors, the software allows pharmacists to enter and store custom therapy-based protocols, drug names, concentrations and dosing limits for standardized programming downloads to CADD^®-Solis pumps.

CADD^™ Medication Cassette Reservoirs and CADD^® Administration Sets -- exclusive reservoirs and sets contain or connect to medication and fit securely onto CADD^®-Solis pumps to promote increased medication security. The pump with reservoirs can fit easily into a pouch so patients can be mobile during therapy.