The FDA announced a class I recall of the Medtronic Hawk One directional atherectomy catheter system due to more than 160 reports of problems with the device’s guidewire. The catheter tip could break or separate when the guidewire prolapses, a problem that is associated with 55 injuries and no deaths, but the recall affects more than 95,000 units.
Medtronic plc released initial results showing meaningful pain relief using differential target multiplexed (DTM) spinal cord stimulation (SCS) endurance therapy, a lower-energy form of its DTM SCS treatment for overall, back or leg pain. At three months, patients in the on-label, prospective, multicenter study reported that their overall pain was about half what it was at the start of the study, measured by a 3.9 cm reduction on the 10 cm Visual Analog Scale (VAS) vs. 7.8 cm at baseline. Patients in the study also reported an average decrease in back and leg pain or 4.3 cm and 5.0 cm, respectively. Medtronic plans to offer the DTM SCS endurance therapy on its rechargeable Intellis and primary cell Vanta platforms.
The existence of prior art isn’t always readily evident when companies in the device and diagnostic spaces file patent applications with the U.S. Patent and Trademark Office (PTO). As it turns out, literature describing that prior art need not be widely distributed to invalidate a patent as Quest Diagnostics Inc., of Secaucus, N.J., recently discovered, an object lesson for all in the med-tech space that research for prior art must be exhaustive if a patent is to hold up over time.
Medtronic plc continued its aggressive acquisition strategy today with the announcement of an agreement to purchase Affera Inc. Medtronic Chairman and CEO Geoff Martha revealed in a presentation on Jan. 10 at the virtual edition of the J.P. Morgan Healthcare Conference that his company was paying $925 million for the cardiac mapping and navigation company. The total reflects $250 million in payments assuming Affera meets “contingent considerations.”
FDA recalls are fairly commonplace events and infrequently require any field corrections of inventory on the market, but Puritan-Bennett Corp. has asked customers to quarantine 135 of the company’s 980 series ventilators due to assembly problems that could cause the devices to cease operating.
Glaciers are known to move slowly, but so is government, and the FDA needed seven years to make effective an order that cerebrospinal fluid shunts be deemed class II devices. The classification was applicable as of Aug. 22, 2014, in connection with a de novo petition filed by no less than industry colossus Medtronic plc, of Dublin, in a process that began in 2012, possibly earlier.
Some U.S. FDA warning letters are mostly about documentation, but the key consideration in the widely publicized Dec. 9 FDA warning letter to Dublin-based Medtronic plc seems to be whether Medtronic had a proper understanding of the risk created by malfunctioning infusion pump retainer rings. That difference of opinion regarding risk took a significant bite out of the company’s shares and boosted the fortunes of its rivals in the diabetes space, a cautionary tale regarding the hazards associated with a failure to understand how the FDA sees the risk of device malfunction. The FDA had reported in October 2021 a pair of recalls of Medtronic’s Minimed insulin pumps, although one of the issues cited was related to cybersecurity concerns. The two recalls affected nearly half a million units combined, and could have significantly affect access for some patients.
The U.S. CMS has crafted a payment policy that covers both adjunctive and non-adjunctive continuous glucose monitors (CGMs) in the final rule for durable medical equipment (DME). Medtronic plc, of Dublin, heralded the move as “a very important benefit expansion” for the company’s customers, but the expanded coverage also pays for additional CGMs that work with Medtronic insulin pumps.
Diabetes care will continue to evolve in 2022. New digital offerings and advanced algorithms, along with new product launches in insulin pumps and continuous glucose monitoring (CGM) will power growth in the future, according to key analysts. While many medical device sectors have suffered during the COVID-19 pandemic, diabetes care has continued to grow.
TORONTO – Cloud Dx Inc. has entered into an exclusive corporate agreement with Medtronic Canada ULC to provide the subsidiary of Medtronic plc virtual and remote patient monitoring (RPM) technology and services across Canada. Medtronic Canada will begin by integrating Cloud Dx’s Connected Health platform along the perioperative and complex chronic disease pathways that make up the country’s health care network.
