Here is a list of ten recent medical devices and technology approved by the FDA.
1. Apollo Endosurgery's SuMO endoscopic tissue access and resection system. The FDA cleared Apollo Endosurgery's SuMO, which stands for Sub-Mucosal Operation, endoscopic tissue access and resection system earlier this month. The system allows surgeons to remove large, flat precancerous gastrointestinal lesions and polyps during endoscopy procedures without leaving scars. The SuMO system was developed through a partnership between Apollo Endosurgery and the Mayo Clinic, Johns Hopkins University, the Medical University of South Carolina and the University of Texas Medical Branch. The system includes flexible injection needles, balloons and cutting tools to help the surgeon tunnel underneath the lesion and resect, seal off and remove the unwanted tissue through a traditional endoscope. Preclinical proof-of-concept studies showed the device to be effective in the removal of gastrointestinal tissue up to 7 cm in diameter.
2. Intuitive Surgical's EndoWrist One Vessel Sealer for da Vinci Surgical System. The FDA cleared Intuitive Surgical's EndoWrist One Vessel Sealer instrument for use with the da Vinci Surgical System earlier this month. The vessel sealer is a wristed, single-use instrument for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that can fit in the jaws of the instrument. The sealer is compatible with all da Vinci Si Surgical Systems by purchasing a dedicated radio frequency energy generator.
3. NinePoint Medical's Nvision VLE Imaging System. NinePoint Medical received FDA 510(k) clearance for its Nvision VLE Imaging System, a high-resolution optical imaging technology for use as an imaging tool in the evaluation of human tissue microstructure, earlier this month. The device provides two-dimensional, cross sectional and real-time depth visualization. The system is also the first FDA-cleared volumetric optical coherence tomography for endoscopic imaging using a circumferential scanning technique and an automatic pullback.
4. Intuitive Surgical's single-site instrumentation for gallbladder surgery. The FDA approved the single-site instrumentation for Intuitive Surgical's da Vinci robotic surgery system that will allow gallbladder removal with one incision in December. The kit includes the Single-Site Port, specialized curved surgical tubes and 5mm semi-rigid instruments, which are designed to reduce instrument crowding and external collisions associated with hand-held, laparoscopic single-incision devices. The instrument was used a few weeks later for the first time by Dr. Santiago Horgan at the UC San Diego Health System.
https://www.beckersasc.com/gastroenterology-and-endoscopy/dr-santiago-horgan-performs-first-single-incision-gallbladder-removal-in-us.html
5. Boston Scientific's Infinion 16 Percutaneous Lead. The FDA approved Boston Scientific's Infinion 16 Percutaneous Lead for its Precision Plus Spinal Cord Stimulator system in early December. This is the first 16-contact percutaneous lead for spinal cord stimulation. Traditionally, leads, which deliver electrical pulses from an implantable pulse generator to the spinal cord, have had a maximum of eight contact points. The extra leads will provide better coverage of the painful area of the spinal cord. The Infinion 16 Lead was introduced at the North American Neuromodulation Society meeting also in December.
6. Philips' PET and MRI whole body scanning system. The FDA approved Philips' whole body scanning system that uses both PET, or positron emission tomography, and MRI to detect cancer in late November. PET identifies cancer cells as they absorb chemical tracers, and MRI views the surrounding tissue. Philips spokesman Steve Klink compared the PET to a GPS system and MRI to the map in a Washington Post report.
7. Boston Scientific's Promus Element Plus chromium heart stent. The FDA cleared Boston Scientific's Promus Element Plus chromium heart stent in late November. The stent is coated with the drug everolimus to prevent clots from reforming in the artery after the wire-mesh tube is inserted. The new stent will replace the Promus stent currently co-marketed with Abbott Laboratories.
8. Aptus Endosystems' EndoStapling system. Aptus Endosystems, a medical device company developing technology for endovascular aneurysm repair, received FDA clearance for the EndoStapling System, now called the HeliF Aortic Securement System in late November. The system uses helical anchor technology to enable independent endograft fixation. It's designed to mimic the hand suturing performed during open surgical repair of abdominal aortic aneurysms. The system also can be used during initial EVAR procedures to enhance fixation and sealing mechanisms.
9. Medtronic's AdaptiveStim neurostimulator. The FDA approved Medtronic's AdaptiveStim with the RestoreSensor neurostimulation system in November. The system uses motion sensor technology to automatically adapt stimulation levels to the needs of people with chronic back and leg pain. It also recognizes and remembers the correlation between a change in body position — as a person is standing, sitting or laying down — and stimulation level and will automatically adjust the level based on body position. It also records the frequency of posture changes.
10. Edwards Lifesciences' Sapien transcatheter device. The FDA's approved Edwards Lifesciences' Sapien transcatheter device in early November. This marked the first time such a device was approved in the U.S. market. The device, which allows coronary valve replacement without open-heart surgery, can now be purchased directly from the company. Sales between $20 million and $25 million are expected in the first three months, and sales between $150 million to $250 million are expected in the first year.
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1. Apollo Endosurgery's SuMO endoscopic tissue access and resection system. The FDA cleared Apollo Endosurgery's SuMO, which stands for Sub-Mucosal Operation, endoscopic tissue access and resection system earlier this month. The system allows surgeons to remove large, flat precancerous gastrointestinal lesions and polyps during endoscopy procedures without leaving scars. The SuMO system was developed through a partnership between Apollo Endosurgery and the Mayo Clinic, Johns Hopkins University, the Medical University of South Carolina and the University of Texas Medical Branch. The system includes flexible injection needles, balloons and cutting tools to help the surgeon tunnel underneath the lesion and resect, seal off and remove the unwanted tissue through a traditional endoscope. Preclinical proof-of-concept studies showed the device to be effective in the removal of gastrointestinal tissue up to 7 cm in diameter.
2. Intuitive Surgical's EndoWrist One Vessel Sealer for da Vinci Surgical System. The FDA cleared Intuitive Surgical's EndoWrist One Vessel Sealer instrument for use with the da Vinci Surgical System earlier this month. The vessel sealer is a wristed, single-use instrument for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that can fit in the jaws of the instrument. The sealer is compatible with all da Vinci Si Surgical Systems by purchasing a dedicated radio frequency energy generator.
3. NinePoint Medical's Nvision VLE Imaging System. NinePoint Medical received FDA 510(k) clearance for its Nvision VLE Imaging System, a high-resolution optical imaging technology for use as an imaging tool in the evaluation of human tissue microstructure, earlier this month. The device provides two-dimensional, cross sectional and real-time depth visualization. The system is also the first FDA-cleared volumetric optical coherence tomography for endoscopic imaging using a circumferential scanning technique and an automatic pullback.
4. Intuitive Surgical's single-site instrumentation for gallbladder surgery. The FDA approved the single-site instrumentation for Intuitive Surgical's da Vinci robotic surgery system that will allow gallbladder removal with one incision in December. The kit includes the Single-Site Port, specialized curved surgical tubes and 5mm semi-rigid instruments, which are designed to reduce instrument crowding and external collisions associated with hand-held, laparoscopic single-incision devices. The instrument was used a few weeks later for the first time by Dr. Santiago Horgan at the UC San Diego Health System.
https://www.beckersasc.com/gastroenterology-and-endoscopy/dr-santiago-horgan-performs-first-single-incision-gallbladder-removal-in-us.html
5. Boston Scientific's Infinion 16 Percutaneous Lead. The FDA approved Boston Scientific's Infinion 16 Percutaneous Lead for its Precision Plus Spinal Cord Stimulator system in early December. This is the first 16-contact percutaneous lead for spinal cord stimulation. Traditionally, leads, which deliver electrical pulses from an implantable pulse generator to the spinal cord, have had a maximum of eight contact points. The extra leads will provide better coverage of the painful area of the spinal cord. The Infinion 16 Lead was introduced at the North American Neuromodulation Society meeting also in December.
6. Philips' PET and MRI whole body scanning system. The FDA approved Philips' whole body scanning system that uses both PET, or positron emission tomography, and MRI to detect cancer in late November. PET identifies cancer cells as they absorb chemical tracers, and MRI views the surrounding tissue. Philips spokesman Steve Klink compared the PET to a GPS system and MRI to the map in a Washington Post report.
7. Boston Scientific's Promus Element Plus chromium heart stent. The FDA cleared Boston Scientific's Promus Element Plus chromium heart stent in late November. The stent is coated with the drug everolimus to prevent clots from reforming in the artery after the wire-mesh tube is inserted. The new stent will replace the Promus stent currently co-marketed with Abbott Laboratories.
8. Aptus Endosystems' EndoStapling system. Aptus Endosystems, a medical device company developing technology for endovascular aneurysm repair, received FDA clearance for the EndoStapling System, now called the HeliF Aortic Securement System in late November. The system uses helical anchor technology to enable independent endograft fixation. It's designed to mimic the hand suturing performed during open surgical repair of abdominal aortic aneurysms. The system also can be used during initial EVAR procedures to enhance fixation and sealing mechanisms.
9. Medtronic's AdaptiveStim neurostimulator. The FDA approved Medtronic's AdaptiveStim with the RestoreSensor neurostimulation system in November. The system uses motion sensor technology to automatically adapt stimulation levels to the needs of people with chronic back and leg pain. It also recognizes and remembers the correlation between a change in body position — as a person is standing, sitting or laying down — and stimulation level and will automatically adjust the level based on body position. It also records the frequency of posture changes.
10. Edwards Lifesciences' Sapien transcatheter device. The FDA's approved Edwards Lifesciences' Sapien transcatheter device in early November. This marked the first time such a device was approved in the U.S. market. The device, which allows coronary valve replacement without open-heart surgery, can now be purchased directly from the company. Sales between $20 million and $25 million are expected in the first three months, and sales between $150 million to $250 million are expected in the first year.
Related Articles on Medical Devices:
Food and Drug Law Institute Report Says FDA Needs to Reform 510(k) Process
St. Jude Medical Plans to Double its Location in Plymouth, Minnesota
Medical Device Tax Already Hurting Jobs, Innovation