Neurovascular Stent Retrievers
As part of its annual Medical Innovation Summit, the Cleveland Clinic released its top 10 medical innovations for 2016. "The list of the technologies that will have the biggest impact in healthcare included neurovascular stent retrievers", which are used after patients suffer an ischemic stroke. Until the FDA-approval of stent retrievers in 2012, a tissue plasminogen activator (tPA) was the only option for removing the clot that occurs within a blood vessel following a stroke. In June 2015, the American Heart Association and American Stroke Association updated its guidelines and added the use of stent retrievers in conjunction with tPA for first-line treatment in some patients with acute ischemic stroke. The stent retrievers are the Solitaire (Medtronic) or Trevo ProVue (Stryker).See Reference 2 below.
Absorbable Stents
Abott Labs -- Absorb stent has already been approved in the European Union. Absorb is made out of a poly-l-lactide acid biopolymer with an everolimus coating and is designed to be entirely reabsorbed over a matter of months after it’s deployed with an advanced catheter-based delivery system.
Naturally controlled artificial limbs-- Bionic Technology
In a pair of studies published in Science Translational Medicine in 2014, researchers are reporting major advances in two areas: guiding prosthetic limbs with realistic tactile feedback, and delivering reliable motor commands. (See Reference 3)
May 20th, 2015 --"Össur Technology Adapts To User’s Subconscious, Intuitive Actions. Two amputees are the first people in the world able to control their Bionic prosthetic legs with their thoughts, thanks to tiny implanted myoelectric sensors (IMES) that have been surgically placed in their residual muscle tissue. Ossur unveiled its implanted myoelectric sensor (IMES) technology at an event in Copenhagen, and is now preparing large-scale clinical trials, in the hopes of reaching the market in three to five years.." (see Reference 4)
Surgical Robotics
Titan Medical surgical robots -The SPORT Surgical System is a versatile single incision advanced robotic surgical system that features state-of the-art multi-articulated instruments with single-use replaceable tips, 3D high definition visualization on a flat-screen monitor, ergonomic open workstation and a single-arm mobile patient cart for ease of set up while enabling broad applications of single and multi-quadrant surgeries previously not possible with current robotic solutions.
Trans-Enterix surgical robots--The SurgiBot™ System is designed to be a minimally invasive surgical platform that allows multiple instruments to be introduced and deployed through a single incision. The flexible instruments may be controlled directly by the surgeon from inside the sterile field, with robotic assistance.
Medtronic's surgical robot when launched will compete with Intuitive Surgical Inc's da Vinci system, the only robot for abdominal surgery now on the market. It is also expected to face competition from Verb Surgical (see below). Medtronic plans to use its surgical robot in every surgery that robots are currently able to perform. While Sunnyvale, Calif.-based Intuitive has a long lead, having had its flagship da Vinci system since 2000 analysts now see a challenge from Medtronics. (see Reference 8).
Johnson & Johnson (J&J) and the parent company of Google have formed an independent surgical solutions company to produce innovative robotic-assisted systems for surgery. Verb Surgical Inc., the name of the new company, is funded by investments from J&J’s Ethicon medical devices subsidiary, J&J Innovation - JJDC, Inc., and a research organization now called Verily – the new name Alphabet has chosen for its life sciences unit. (See Reference 6)
Stryker's ($SYK) Mako robot was recently cleared by the FDA for total knee reconstruction following the $1.65 billion acquisition of Mako Surgical in 2013.
Cathers
Catheters have become an integral part of the modern healthcare system and are driving innovation in the industry. The most common is the catheter Foley catheter, designed to serve a basic function in the urinary tract. The earliest American invention of the flexible catheter was during the 18th century. Extending his inventiveness to his family's medical problems, Benjamin Franklin invented the flexible catheter in 1752 when his brother John suffered from bladder stones. Being able to detect that a catheter is infected can help prevent antibiotic resistance, lessen the burden on clinicians, reduce costs, and lead to better clinical outcomes for patients. At the University of Bath in England (reference 11) researchers have created a coating that when applied to catheter tips will change the color of urine flowing into collection bags.
Artificial Pancreas
Artificial Pancreas from Medronics could hit the market by 2017 --Medtronic has reportedly filed for FDA approval of an “artificial pancreas” that could transform diabetes care. The medical device giant thinks its MiniMed 670G product could hit the market in 2017, according to Bloomberg.
Public Workshop - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers, October 27-28, 2016
Public Workshop - Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices, September 30, 2016
Public Workshop - Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests - September 23, 2016
FDA/Patient Workshop - Partnering with Patients on CDRH’s Research Agenda for Assistive and/or Neurostimulation Devices, August 1, 2016
Public Workshop - Liquid Biopsies in Oncology Drug and Device Development, An FDA-AACR public workshop, July 19, 2016
Workshop - 9th Annual Medical Device and Diagnostics Statistical Issues, Co-Sponsored by AdvaMed and FDA, May 3-4, 2016
Public Workshop - Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices, May 2, 2016
Public Workshop - Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids, April 21, 2016
Public Workshop - Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy, March 18, 2016 (New Date)
CDRH Industry Basics Workshop - Unique Device Identification (UDI) Part II, Submitting Information to GUDID, March 10th, 2016
Public Workshop - Advancing the Development of Biomarkers in Traumatic Brain Injury, March 3, 2016
Public Workshop - Patient and Medical Professional Perspectives on the Return of Genetic Test Results, March 2, 2016
Public Workshop - Next Generation Sequencing-Based Oncology Panels, February 25, 2016
CDRH Industry Basics Workshop - Unique Device Identification (UDI), January 27, 2016
Public Workshop - Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy, March 18, 2016 (New Date)
Public Workshop - Moving Forward: Collaborative Approaches to Medical Device Cybersecurity, January 20-21, 2016
See FDA --2016 Medical Device Meetings and Workshops for details.
Readings and References
1-Medical Device Pipeline 2016
2-Stent retrievers make Cleveland Clinic’s top 10 medical innovations for 2016
4-Össur Introduces First Mind-Controlled Bionic Prosthetic Lower Limbs for Amputees
5-Robotic surgery to see new entrants Medtronic and J&J/Google, but Intuitive still miles ahead
6-J&J and Google Form New Company For Surgical Robot Venture
7-Medtronic expects revenue from surgical robot in fiscal 2019
8-Analyst: Medtronic most likely to challenge Intuitive Surgical in robot-assisted surgery
9-How catheters are driving healthcare innovation
10-DSM partners with Vention Medical to provide single-source solution for catheters and coatings
11-An in-situ infection detection sensor coating for urinary catheters