The 2022 Vascular Interventional Advances (VIVA) medical meeting, which concluded on Nov. 3 in Las Vegas, focused on advances in interventional cardiology and devices to improve vascular health with the expected studies comparing drug-eluting balloons, new stents and less invasive procedures. One Boston Scientific Corp. presentation put the rest into context, however, with one of the most critical advances in cardiology, enrollment in the Drug-Eluting Registry: Real World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE) registry.
Medtronic plc reported six-month results from the full cohort of its Spyral HTN-ON MED study, showing a statistically significant reduction in office-based blood pressure, a key secondary endpoint. However, the trial missed its primary efficacy endpoint of a reduction in 24-hour systolic blood pressure, compared with a sham procedure.
Just as the U.S. FDA gathered industry leaders to address the issues posed by pulse oximeters that provide inaccurate measurements for individuals with darker skin, Biointellisense Inc. released its own FDA-cleared technology that provides accurate readings regardless of skin tone. The challenge of inaccurate readings for people with darker skin came to the fore with the COVID-19 pandemic as fingertip pulse oximeters emerged as a convenient method of monitoring for hypoxia at home and in clinics, but frequently overreported oxygen levels in the blood of people of color, leading to delayed treatment.
Medtronic plc has launched Medtronic Neurovascular Co-Lab platform, a major initiative to speed the pace of innovations in stroke treatment and access for patients around the world. The neurovascular innovation incubator will bring together innovators, entrepreneurs and physicians to collaborate and share their ideas about promising products and solutions.
Ernst & Young’s (EY) annual Pulse of the Industry report offers plenty of reasons for optimism within med tech as the impact of the pandemic recedes, while identifying several key areas that will require continued focus for the sector’s long-term success.
After years of aggressive acquisitions, Medtronic plc joined 3M Co., General Electric Co. and Johnson & Johnson in rationalizing its business by splitting into more focused enterprises. Medtronic will separate its patient monitoring and respiratory therapy groups into a new company with projected annual revenue of $2.2 billion and 8,000 employees in the next 12 to 18 months, assuming regulatory and final board approvals.
The annual North American Spine Society (NASS) Conference wraps up in Chicago on Oct. 15 and management discussions and analysts make it clear that the sector is not yet back to normal. While September showed an uptick in procedures, spinal surgery continues to lag the recovery seen elsewhere in orthopedics. As the challenges of the past two years recede, two players have posted notable gains in market share and revenue—Globus Medical Inc. and Alphatec Holdings Inc.—perhaps indicating a competitive advantage for smaller, more agile companies.
Getinge AB reported a partnership with Medtronic plc for the Radiant stent, the first covered stent indicated for chimney endovascular aneurysm repair (ChEVAR). This new balloon-expandable stent graft for renal arteries obtained CE mark approval on Sept. 20.
Colorectal cancer (CRC) is expected to increase steadily through the decade to reach more than 2.2 million cases and 1.1 million deaths by 2030 as two concurrent trends tick up—an aging population, that typically has higher rates of the disease, and an alarming increase in cases in younger people. Iterative Scopes Inc. hopes to help gastroenterologists find precancerous lesions before they progress with its Skout device, which received U.S. FDA 510(k) clearance this week.
The U.S. FDA posted notice recently regarding a vulnerability seen in the Minimed 600 series of insulin pumps made by Dublin-based Medtronic plc, which exposes the user to the risk of unauthorized access to the pump’s software. The vulnerability could be exploited to interfere with the system’s ability to deliver only the desired amount of insulin, although the FDA acknowledged that no adverse events or complaints have been reported.