Some major regulatory announcements took centre stage in our most read articles of December, with the top story revealing that the Swiss Federal Assembly had voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation. This was closely followed by some interesting research on postoperative wound drains for patients undergoing posterior spinal decompression and fusion. Rounding out the top three was the news that the EU Commission are looking to delay the implementation of their Medical Device Regulation. There were also some industry announcements from the likes of VYRSA Technologies and Providence Medical Technology in this month’s top 10.
1. Swiss parliament votes to accept US FDA-approved medical devices
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
2. Postoperative wound drains not recommended in some patients undergoing posterior spinal decompression and fusion
In patients undergoing primary posterior spinal decompression and fusion up to three levels for degenerative lumbar disorders, the use of postoperative drains is not recommended. This is according to a recent multicentre, prospective, randomised controlled clinical trial, the results of which were published online in The Spine Journal by Marcelo Molina (Clínica Las Condes, Santiago, Chile) et al.
3. EU Commission to propose delay to MDR implementation
Europe’s health commissioner, Stella Kyriakides, has announced that proposals to extend the transition period for the implementation of the European Union’s (EU) Medical Device Regulation (MDR) will be put forward in early 2023.
4. Type of cervical disc herniation on MRI does not correlate with clinical outcomes
In patients with cervical radiculopathy, the type and extent of disc herniation measured on magnetic resonance imaging (MRI) prior to surgery correlated neither to the severity of the symptoms at presentation, nor to clinical outcomes at two years postoperatively. This is according to new research, published in The Bone and Joint Journal by Xiaoyu Yang (Leiden University Medical Centre, Leiden, the Netherlands) et al.
5. VYRSA Technologies announces worldwide launch of VYRSA V1 SI fusion system
VYRSA Technologies has announced US Food and Drug Administration (FDA) clearance of its VYRSA V1 sacroiliac (SI) fusion system.
6. Posterior surgery non-inferior to anterior surgery for cervical foraminal radiculopathy patients, new randomised trial shows
Posterior cervical foraminotomy is non-inferior to anterior cervical discectomy with fusion for patients with cervical radiculopathy in relation to procedural success rate and reduction in arm pain at one year. This is according to the latest results from the FACET randomised controlled trial, which were published by Anne Broekema (University of Groningen, Groningen, The Netherlands) et al in JAMA Neurology.
7. Non-pharmacological interventions more beneficial for patients with chronic low back pain without radiculopathy, but more evidence needed
For patients with chronic non-specific low back pain without radiculopathy, non-pharmacological interventions of acupuncture and spinal manipulation provide safer benefits than pharmacological or invasive interventions. This is according to a new systematic review and meta-analysis—published in The Spine Journal by co-lead author Stephanie Mathieson (The University of Sydney, Sydney Australia) et al—which did however note that more research on the subject is needed, as only a limited number of trials have been conducted.
8. CAVUX facet fixation system granted FDA approval for the treatment of cervical pseudarthrosis
Providence Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared its CAVUX facet fixation system (FFS) for a new indication—patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.
9. Insurance plan affects access to and timeliness of surgery for patients with cervical degenerative conditions
Insurance type has a significant impact on incidence and time-to-occurrence of surgery for patients with cervical degenerative conditions, according to new research—published in the journal Spine by Amit Jain (Johns Hopkins University, Baltimore, USA) et al—which also indicated that patients with high-deductible health plans (HDHP) may experience higher costs, thus potentially limiting their access to care.
10. Top US spinal organisations launch new Coalition for Spine Health
The US National Spine Health Foundation (NSHF) has announced the launch of a first of its kind Coalition for Spine Health. The coalition will initially bring together four of the USA’s leading spinal organisations to advance awareness and patient education.