DUBLIN, Nov. 15, 2021 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), a global leader in healthcare
technology, today announced that the U.S. Food and Drug
Administration (FDA) has granted 510(k) clearance for its PillCam™
Small Bowel 3 system for remote endoscopy procedures. The PillCam™
SB3 @HOME program combines Medtronic's PillCam technology with
Amazon logistics, a combination intended to ensure both timely and
accurate results for patients from the comfort of their homes.
PillCam SB3 @HOME provides a telehealth option for direct
visualization and monitoring of the small bowel, to help better
detect lesions not detected by upper and lower endoscopy that may:
1) indicate Crohn's disease, 2) locate obscure bleeding, or 3)
identify sources of iron deficiency anemia (IDA).
"As the future of medicine continues to move toward remote
settings, we have great opportunity to deliver diagnostic testing
and other minimally invasive procedures from patients' homes," said
Giovanni Di Napoli, president of the
Gastrointestinal business, which is part of the Medical Surgical
Portfolio at Medtronic. "The pandemic necessitated more remote
innovation, and our capabilities have exceeded expectations to
provide better quality care to patients without the risk of COVID
infection and without adding to the burden on the medical staff.
PillCam SB3 @HOME offers a convenient option for a contactless
procedure and helps ensure that patients can access care in a
timely manner."
The system is designed to deliver images of the mucosa and
offers innovative features, such as adaptive frame rate technology,
to support image acquisition that is uniquely suited to each
patient's motility, as well as the tools needed to record those
images and allow the clinician to interpret study results. The
software's advanced technology helps providers read and interpret
study results, efficiently.
"Early diagnosis and treatment are key to achieving the best
outcome for GI patients, and fortunately with telehealth options,
patients can receive their GI diagnosis conveniently from home,"
said Dr. Michael Bass of GI
Specialist of Delaware. "The
COVID-19 pandemic has underscored the importance of early detection
and not delaying care following the onset of symptoms. This system
allows for patients to remain in the comfort and safety of their
own home while giving providers access to the high-quality images
needed to make a diagnosis."
PillCam Small Bowel 3 is only cleared for remote use in the U.S.
It is not approved for this use in other geographies.
About PillCam™ SB3 @Home
Once a GI physician
identifies a patient and places an order for a PillCam SB3 @HOME
procedure kit, the procedure date is confirmed and the PillCam SB3
@HOME kit is delivered directly to the patient. Through a
telehealth appointment, a healthcare provider guides the patient
through the remote procedure, and the patient returns the data
recorder and sensor belt to Medtronic once the procedure is
complete. Over the course of the eight-hour procedure, the
PillCam SB3 capsule transmits approximately 50,000 images. These
images are securely transferred to the cloud where there are
accessed by a GI physician who reviews the images to make a
diagnosis.
Prior to the 510(k) clearance, PillCam SB3 @HOME was given
temporary FDA-approval during the National Public Health Emergency.
Medtronic's PillCam™ capsule endoscopy has been used for more than
20 years as a minimally invasive, patient-friendly option for the
detection of gastrointestinal diseases. PillCam SB is now in its
3rd generation and has impacted more than 4 million patients
worldwide.
About Medtronic
Bold thinking. Bolder actions. We are
Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global
healthcare technology company that boldly attacks the most
challenging health problems facing humanity by searching out and
finding solutions. Our Mission — to alleviate pain, restore health,
and extend life — unites a global team of 90,000+ passionate people
across 150 countries. Our technologies and therapies treat 70
health conditions and include cardiac devices, surgical robotics,
insulin pumps, surgical tools, patient monitoring systems, and
more. Powered by our diverse knowledge, insatiable curiosity, and
desire to help all those who need it, we deliver innovative
technologies that transform the lives of two people every second,
every hour, every day. Expect more from us as we empower
insight-driven care, experiences that put people first, and better
outcomes for our world. In everything we do, we are engineering the
extraordinary. For more information on Medtronic (NYSE:MDT), visit
www.Medtronic.com and follow @Medtronic on Twitter and
LinkedIn.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
Contacts:
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SOURCE Medtronic plc