A Cambridge UK technology that will enable doses of an intravenous anaesthetic to be personalised for individual patients during operations, has won a key approval in Europe.Sphere Medical’s Pelorus 1500 has achieved CE Marking as an in-vitro diagnostic medical device. The CE mark enables Sphere Medical to sell the solution in all member states within the European Economic Area.
The Pelorus 1500 is the world’s first point-of-care in-vitro diagnostic medical device for the rapid measurement of the concentration of the intravenous anaesthetic propofol in blood samples and has been developed specifically for anaesthetists in the critical care setting.
Sphere says that it will – for the first time – allow anaesthetists to know the actual rather than predicted concentration of propofol, allowing the personalisation of dosing to the patient.
Propofol is one of the world's most widely used intravenous anaesthetics, used for the induction and maintenance of general anaesthesia in the operating room and general sedation in the intensive care unit.
Each year, around 12 million patients are admitted to the ICU in the developed world and around eight million are sedated during treatment. Monitoring of inhaled anaesthetic gases is already a standard of care, but there is no equivalent measurement used for intravenous anaesthetics such as propofol.
Sphere Medical expects the Pelorus 1500 to be used in conjunction with existing commercially available dosing pumps. Clinical studies have already shown that a single measurement carried out during general anaesthesia can significantly improve the clinicians’ understanding of propofol levels during an operation.
The company is working with leading anaesthetists in the UK to investigate approaches to use propofol measurements during infusion to tailor the dose to the patient. This is expected to result in the next generation of infusion control systems, which represents a significant opportunity to improve patient care so is a large commercial opportunity.
Sphere says it has received some early indications of interest in the Pelorus 1500 from potential commercial partners with whom it has an ongoing dialogue.
CEO Stuart Hendry said: “Obtaining the CE Mark for the Pelorus 1500 was a milestone we set down at the time of the IPO and we have achieved this on time and within budget.
“We now intend to capitalise on the early interest being shown by a number of medical device companies and are already working with a number of leading anaesthetists.”