Medical Device Maker Seeks FDA and EU Approval Of Pain-Free Blood Collection Device
|XTALKS VITALS NEWS
The device – called the TAP100 Touch Activate Phlebotomy – uses microneedles to draw blood from small capillaries, eliminating the need to puncture a vein or fingertip.
April 15, 2016 | by Sarah Massey, M.Sc.
Health technology company Seventh Sense Biosystems, have announced they have begun registration for a pivotal clinical trial for their painless drug collection device. The device – called the TAP100 Touch Activate Phlebotomy – uses microneedles to draw blood from small capillaries, eliminating the need to puncture a vein or fingertip.
According to Seventh Sense, their goal was to develop a point-of-care device that would facilitate easier blood collection, compared to standard phlebotomy techniques that are only performed in dedicated diagnostics facilities. The company hopes to use the upcoming trial data to support both Food and Drug Administration (FDA) and European new device applications.
Seventh Sense plans to file for marketing authorization to the two regulatory authorities in the second quarter of this year. They anticipate quick approval of the device, meaning they could potentially receive FDA approval and CE Mark later this summer.
“We are excited to begin the registration trial with the company's lead product, the innovative TAP100 blood collection device,” said Howard Weisman, CEO of Seventh Sense Biosystems. “Under the current system, anyone giving blood for diagnostic tests has to undergo a procedure that is inconvenient, scary and painful. While diagnostics, treatments and therapeutics in medicine continue to advance, current blood collection practices ignore trends making healthcare more convenient and accessible.”
An early version of the device – called TAP20-C – collected blood from the fingertip as opposed to the forearm. According to data collected from ClinicalTrials.gov, two trials aimed at testing that particular device have since been withdrawn.
“The start of our pivotal trial moves us closer to delivering this device to patients and physicians, ultimately enabling blood collection to be performed whenever and wherever it is needed, and by anyone,” said Weisman. “Our goal is to enable clinicians and patients to get vital health and disease status information more quickly.”
The trial will involve 120 patients spread over three hospitals in the Northeast US. The company had originally planned to gain FDA approval of the device in 2013, with their launch date set for 2014.
Over 1,000 patient have already used the device, few of which have reported pain according to Seventh Sense. The company notes that at least 20 percent of adults have a fear of needles, and as venipuncture is one of the most commonly-performed medical procedures, the phobia could cause some patients to avoid medical treatment.
“Blood collection for testing with TAP100 is convenient and painless, and its availability is intended to increase patient compliance with necessary test orders, providing doctors with more timely data on which to base diagnoses and treatment decisions,” said Weisman. “Increasing compliance by removing barriers to blood-based diagnostics will ultimately lead to better health outcomes.”
Keywords: Medical Device, Clinical Trial, FDA Approval
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