Part
01
of two
Part
01
Coflex and Spinal Fusion Procedures
As of 2018, there were about 1.62 million spinal fusion procedures performed in the US. Unfortunately, there is no information in the public domain specific to the number of Coflex procedures performed annually in the United States. However, using information pertinent to when Coflex was introduced, the research team estimated the average number of Coflex procedures performed yearly in the world since its inception at 13,583.
SPINAL FUSION PROCEDURES PERFORMED ANNUALLY
- iData Research's study in 2018 revealed that around 1.62 million spinal fusion procedures performed in the US yearly.
- Out of the annual spinal fusion procedures conducted in the United States, interbody fusions were the ones most commonly performed, with more than 352,000 performed yearly in the US, according to iData Research.
- Cervical fixation is another significant type of spinal fusion procedure in the US. As of 2017, 85.5% of this type of spinal procedure were anterior while 14.5% of them were posterior, as per the study by iData Research.
- However, the number of spinal fusion procedures performed in the United States jumped from 1.187 million in 2007 to over 1.391 million in 2011. Within these periods, the number of patients it was performed on went from 662,400 in 2007 to 741,700 in 2011, according to a 2014 report by Bone And Joint Burden.
FINDINGS RELEVANT TO THE NUMBER OF COFLEX PROCEDURES PERFORMED ANNUALLY
- Globally, the Coflex procedures have been performed on over 163,000 patients in more than 60 countries since its inception, as per information on Coflex's official directory. Unfortunately, the company did not provide data showing the number of procedures performed in the United States alone; neither is such information available for any country.
- According to the United State's National Library of Medicine, Coflex received its investigational device exemption (IDE) in 2006 before its approval by the FDA in October 2012.
- Based on the number of Coflex procedures performed global and the date it received its investigational device exemption in 2006, we took it that the Coflex procedures began in 2006 (which is 12 years as of 2018). Thus, we estimated the average number of Coflex procedures performed annually to be 13,583 globally, as there is no data in the public domain specific to the United States.
RESEARCH STRATEGY:
We began by investigating authoritative medical research directories, including the US National Library of Medicine, Science Direct, Becker's Spine Review, and others in search of data showing the number of Coflex and spinal fusion procedures performed annually in the United States. This research produced studies by iData Research, Bone And Joint Burden, and others, which revealed the number of spinal fusion procedures performed in the US, as well as its historical data. Unfortunately, there was no study in the public domain showing the number of Coflex procedures conducted annually in the United States.
Therefore, we proceeded to investigate the official directory of Coflex, hoping to find information relevant to the number of procedures performed in the US alone. This time, we found a report by the company stating that the Coflex procedures have been performed on over 163,000 patients in more than 60 countries since its inception. However, there was no data or report by the company with insights into the number of procedures performed in the US for any of the years it received approval in the US.
Next, we switched strategies to research medical organizations in the US that perform the Coflex procedure for patients. This time we hoped to locate the total number of such institutions and the number of procedures each performed yearly. Unfortunately, this effort did not provide relevant information. Instead, we located studies conducted by several organizations such as Science Direct, Spine Research, Becker's Spine Review, the US National Library of Medicine, and others. These studies tested the clinical effectiveness of Coflex on a sample of patients in the US, but did not provide any data showing the number of procedures conducted annually in the US. However, the US National Library of Medicine's study revealed that Coflex received its investigational device exemption (IDE) in 2006 before its approval by the FDA in October 2012. Based on this information, we took it that Coflex had been in existence since 2006.
Hence, due to the lack of information specific to the United States, we estimated the number of Coflex procedures performed annually worldwide using the information available in the public domain, as a proxy for the required data.
CALCULATION
According to Coflex, over 163,000 patients in more than 60 countries have used its procedure since its inception. The company's webpage having this information had a copyright date showing 2019 in its footer, so we took it that this data was the most recent information and was for 2018 downward since 2019 is still in progress.
Next, based on the information by the US National Library of Medicine that Coflex received investigational device exemption (IDE) in 2006, we took it that the use of Coflex procedures began in 2006. Thus, from 2006 to 2018, it has been in use for 12 years (2018-2006).
Hence, if Coflex has been used on 163,000 patients in the world for an estimated 12 years, we calculated the average number of Coflex procedures performed annually around the globe since its introduction, as follows:
[163,000/12] = ~13,583.