Olympus America Inc.

08/26/2024 | Press release | Distributed by Public on 08/26/2024 07:25

Olympus Launches New POWERSEAL™ Sealer/Divider 5mm Devices, Extends Advanced Bipolar Surgical Energy Portfolio

POWERSEAL Family of Devices Offers Surgeons Ergonomic Comfort and The Power of Choice in the OR

WESTBOROUGH, Mass., (August 26, 2024) - Olympus Corporation, a global medical technology company committed to making people's lives healthier, safer, and more fulfilling, announced today the launch of two new jaw designs in the POWERSEAL™ Sealer/Divider family of advanced bipolar surgical energy products: the POWERSEAL Straight Jaw, Double-action (SJDA) and the POWERSEAL Curved Jaw, Single-action (CJSA). The first POWERSEAL device, launched in 2021, is the POWERSEAL Curved Jaw, Double-action (CJDA), which has established a strong foothold for Olympus in the advanced bipolar surgical energy market.

The POWERSEAL Sealer/Divider family of devices now includes three jaw designs each available in three shaft lengths to support surgeon preference and technique for dissection, grasping, and sealing during surgical procedures. These devices are designed to meet the highest standards of clinical performance for advanced bipolar surgical energy devices by consistently delivering secure and fast vessel sealing.1 The devices are designed to promote procedural efficiency and surgeon comfort with a multifunctional feature set and carefully considered ergonomics. Each POWERSEAL design requires less squeeze force than competitor devices to close the jaws, without sacrificing jaw force or sealing capability.1

The POWERSEAL family of devices augment an already extensive and diverse surgical energy portfolio, which features the unique THUNDERBEAT™ hybrid energy devices and SONICBEAT™ ultrasonic dissectors. Olympus is competitively positioned within the growing global market for advanced bipolar surgical energy devices, currently estimated at more than $950M USD with a CAGR of more than 3%.2

The POWERSEAL devices provide surgeons with reliable sealing, dissection, and grasping capabilities in laparoscopic or open surgery while reducing the force required by the surgeon to close the jaws.3 The POWERSEAL devices are indicated for use in numerous surgical procedures including general surgery, gynecological, colorectal, bariatric, urological, thoracic, and vascular procedures.4

The POWERSEAL single-use devices are designed with features including:

  • Confident vessel sealing: Strong and efficient sealing of vessels, including pulmonary vessels, tissue bundles, and lymphatics, up to and including 7mm5,6,7,8,9,10,11,12,13,14
    • Greater than 99% probability of vessel burst pressure above 360 mmHg, regardless of vessel size ≤ 7mm.2
    • Minimized tissue sticking on par with nano-coated products. In pre-launch clinical cases, 97% of surgeons indicated that the number of jaw cleanings required with POWERSEAL is Equivalent, Fewer, or Substantially Fewer than required by their current energy device.2,15,16
  • Multifunctional capabilities: Three jaw designs support the surgeon's preference and technique for dissection, grasping, and sealing. All POWERSEAL jaw styles are available in three shaft lengths for laparoscopic and open procedures.17,18,19,20
    • Energy activation without the requirement to fully close the jaws facilitates spot coagulation of surface bleeders or activation on thick tissue, when desired.21
    • Increased dissection force supports separation of tissue planes during dissection.
  • Ergonomic comfort: Reduced distance to device controls, e.g. jaw lever and energy activation button, reduced squeeze forces, smooth jaw rotation, and a contoured handle are designed to promote comfort and ease of use.10

Each POWERSEAL Sealer/Divider requires less squeeze force to close the jaws without sacrificing jaw force or sealing capability.22

"We are very excited to expand our advanced bipolar surgical energy portfolio with the addition of these two new POWERSEAL devices. Meeting physician needs continues to be the primary driver of the product design and functionality," said Phil Roy, Global Vice President and General Manager for Surgical Devices in the Therapeutic Solutions Division of Olympus Corporation. "POWERSEAL devices are developed with a commitment to meeting our goals of sealing strength, efficiency and physician comfort."

Olympus offers hospitals an energy solution for any operating room with the new ESG-410 Surgical Energy Platform, which powers the full range of Olympus Energy systems, including monopolar, bipolar (HiQ™, HICURA™, PK™ and Everest™ devices), ultrasonic (SONICBEAT devices), hybrid energy (THUNDERBEAT devices) and advanced bipolar (POWERSEAL devices). By operating from one energy platform, hospitals may potentially reduce capital expenditures while meeting the other goals of the Quadruple aim23, availing themselves of a range of surgical energy technologies that have been designed with both the patient and the physician in mind.

Advanced bipolar energy devices are distinguished from traditional bipolar energy devices through regulating energy delivery, continuous tissue monitoring, and uniform pressure applied to the tissue by the device jaws. These attributes enable advanced bipolar technologies to deliver more consistent (7mm) vessel sealing than standard bipolar technology counterparts.24

As outlined in the Instructions for Use, reusing or re-sterilizing the POWERSEAL™ devices can cause excessive wear and degradation of device performance as well as possible cross-contamination, which may potentially affect patient safety. Use of the POWERSEAL devices with non-Olympus generators may result in undesired tissue effect or injury to the patient or to the surgical team. The POWERSEAL devices should not be used in patients who have electronic implants without first consulting a cardiologist. Other risks are associated with lack of training, use with an energized endoscope that is not a Type CF applied part, use with a patient with vascular pathology and use at high current for long durations.

The new POWERSEAL SJDA and CJSA devices are regulatory cleared for sale in the U.S., Puerto Rico, Canada, Australia, the E.U. and Thailand at this time. The POWERSEAL CJDA device is being sold in all global regions, except China.

For more information about the POWERSEAL family of devices, visit OlympusAmericaMarketing.com/Ease-the-Squeeze.

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About Olympus
As a leading medical technology company, Olympus uses medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures with the goal of improving clinical outcomes, reducing overall costs, and enhancing the quality of life for patients. Olympus' Medical portfolio includes, but is not limited to, endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of EndoTherapy devices. For more information, visit medical.olympusamerica.com.

1Internal report DN0046457

2Laparoscopic Energy Market Model 2022 (USD)

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4IFU PN0030185

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23Bodenheimer T, Sinsky C. From triple to quadruple aim: care of the patient requires care of the provider. Ann Fam Med. 2014;12(6):573-576. doi:10.1370/afm.1713

24Internal report DN0043135