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The inflatable laparoscopic retractor developed by LapSpace Medical leaps to commercialization stage with the CE Mark
LapSpace Medical announced this week that it has added the CE Mark to its list of milestones. The Company, which has developed an inflatable retractor, previously received FDA certification for its product in the United States. Fifty successful procedures, and a clinical study at Johns Hopkins Hospital in Baltimore, Maryland, have been performed using the LapSpace retractor.
During these procedures, it was discovered that beyond the intended purpose of the device – retraction of the small intestines — the device is also suitable for other applications, for example, retraction of larger, heavier organs such as the liver. Retraction of the liver is most often required during gallbladder removal surgery and gastric bypass procedures Thus, this “discovery” from study and surgical results, points to an increase in the potential market for the product, with over 8 million laparoscopic procedures a year.
Laparoscopic procedures have become the surgical standard, however, one of the challenges remains optimal exposure of the surgical site. The LapSpace retractor, gently and effectively “catching” and retracting internal organs to create a stable operating field during laparoscopic procedures, addresses this challenge. Additionally, the device’s self-retaining clamp keeps it in place for long periods of time, without the need for additional surgical personnel.
Assaf Livne, CEO of LapSpace Medical, remarks: “The success of the procedures confirms the efficacy and quality of results and demonstrates the potential for reducing surgery time and reducing the risk of complications. LapSpace has recorded a series of successes in a relatively short time, ranging from raising funds through the FDA certification for distribution of the product in the United States, to receiving the CE Mark, which allows us to market the product in Europe. We believe that very soon LapSpace will position itself as the leading standard organ retraction solution.”