Pristine Surgical has launched Summit 4K, a single-use surgical arthroscope in centres around the US, after the first-in-human procedure this year.
According to Pristine Surgical, Summit is a first-of-its-kind 4K single-use surgical arthroscope, designed to address the difficulties that come with traditional surgical visualisation.
It combines a 4K single-use surgical arthroscope with Pristine Connect, a cloud-based software, to provide a high-definition image with a new device every time.
The medical technology manufacturer secured 510(K) clearance for the device from the US Food and Drug Administration (FDA) in January 2023, and the first-in-human procedure using the device was carried out in April 2023 by Dr Mark Getelman at the Southern California Orthopedic Institute (SCOI) in the US.
In the announcement, Pristine’s chief medical officer Stephen Snyder said: “We developed Summit to address the challenges inherent to conventional surgical visualisation—which relies on reusable arthroscopes that become obsolete, are difficult and costly to maintain and are prone to wear, damage, and potential infection,”
“It is a major leap forward in a field that hasn’t changed much in my 40-plus years of practice, and when we saw the positive response and impact it was having in our limited market rollout, we were confident it was time to fully launch Summit in the marketplace.”
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According to GlobalData’s Medical Intelligence Center, Pristine Surgical has two marketed arthroscopes, Summit and its Pristine Scope, another single-use, minimally invasive device. Pristine Scope gained 510(K) approval in April 2020.
GlobalData forecasts that the US arthroscope market will increase from $36.4m to $42m in 2030. The market insights credit the growth of the market to the benefits of arthroscopic procedures, which include shorter recovery times, minimal post-operative complications, and greater precision while performing surgeries.
Other players in the market include US-based medical device developer Integrated Endoscopy’s second-generation NUVIS single-use arthroscope, which features a built-in, battery-powered LED and supports a 4K camera system without any additional equipment.