Task force gives CAS screening another thumbs down
The U.S. Preventive Services Task Force (USPSTF) recommended against screening for asymptomatic carotid artery stenosis (CAS) in the general adult population, giving the notion of such screening a grade of D. The task force had rendered the proposition the same grade in its last analysis, which was published in 2014, but an analysis of the literature in the intervening seven years yielded no studies that directly measured the benefits and/or harms of screening for asymptomatic CAS. In that time, two studies were initiated to evaluate the comparative effectiveness of revascularization via endarterectomy versus stenting plus medical management, but both studies were halted prior to completion. Two ongoing studies, including CREST-2, are examining the question of revascularization versus medical management in asymptomatics, but existing registry data report widely varying rates of stroke and death at 30 days, which the task force said is suggestive of issues associated with both patient and operator selection.
USPTO expands program with Japan’s, South Korea’s patent offices
The U.S. Patent and Trademark Office (USPTO) announced an extension of the expanded Collaborative Search Pilot (CSP) program with the patent offices of Japan and South Korea, which was undertaken to make patent searches more efficient across all three agencies. The first iteration of this program consisted of a three-year adoption of administrative procedures designed to facilitate work-sharing between USPTO staff and counterparts at the Japan Patent Office (JPO) and Korean Intellectual Property Office (KIPO), which allowed the participants to share the results of related counterpart applications. Feedback from that first two-year run was sufficient to warrant a two-year extension, which will be used to determine whether sharing of the results of searches leads to greater efficiency and quality of patent examinations. USPTO said that as matters stand, entities who apply for U.S. patents may receive search results and any uncovered prior art while prosecution of their patent applications is ongoing, and that applicants “often … submit the prior art after examination on the merits is already underway in their U.S. application.” Any determination that prior art was uncovered by JPO or KIPO searches can add drag to the examination time in the U.S., which might also incur additional costs to the applicant. Another issue is that the application may be completed and result in grant of patent before the other patent office has forwarded the results of its search for prior art to the applicant. This two-year extension also allows applicants to request that multiple intellectual property offices exchange the results of their individual searches for prior art before issuing a final action on the application. There are several requirements for applicants to take part in the program, such as that the application be a non-reissue, non-provisional utility application, and that the applicant agree to forgo any refund of search fees and/or excess claim fees after the USPTO has responded via mail that the application has been admitted into the program. The extension expires Oct. 31, 2022, and each of the three participating offices will accept no more than 400 requests per year per partner office.
Boston Sci recalls electrode for ICD due to risk of fracture
The U.S. FDA announced a recall of the model 3501 subcutaneous electrode used with the Emblem subcutaneous implantable cardioverter defibrillator (ICD) system by Boston Scientific Corp., of Marlborough, Mass., due to the risk of electrode fracture. The potential for fracture is located between the distal sensing tip and the proximal sensing ring, which could result in a failure to delivery therapy for tachycardia. The agency said 27 complaints have been received, with 26 reports of serious injury and one fatality. Just short of 20,000 devices distributed in the U.S. between June 2017 and November 2020 are affected by the recall. Physicians are advised to conduct remote monitoring of affected patients and follow up with patients every three months either remotely or in person to assess the electrode for any indications of potential fracture. Any electrodes that demonstrate a potential for fracture, such as the occurrence of high impedance alerts or a positive radiographic finding, should undergo electrode replacement, although the FDA does not endorse replacement of electrodes in the absence of evidence of fracture.
CDSCO posts lists of approved tests
India’s Central Drugs Standard Control Organization (CDSCO) added two items to its updates page, including a list of PCR kits approved for testing for the COVID-19 pandemic. The 177-entry PCR list is current as of Feb. 2, and includes a number of kits manufactured in India, such as the TruPCR by Kilpest India Ltd. The agency also posted a lit of rapid test kits numbering 128 entries.