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【medical-news】Ethicon Endo-Surgery, Inc., Receives FDA 51
Main Category: Medical Devices News
Article Date: 15 Oct 2006 - 0:00am (PDT)
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Ethicon Endo-Surgery, Inc., announced today at the American College of Surgeons 92nd Annual Clinical Conference in Chicago that the U.S. Food and Drug Administration (FDA) recently granted 510 clearance for HARMONIC WAVE, designed for use exclusively in open surgery.
HARMONIC WAVE, an ergonomically designed advanced energy surgical device specifically for the needs of colorectal and gynecological surgeons simultaneously cuts and coagulates 5 mm vessels and minimizes lateral thermal spread to 2 mm on either side.
The Ethicon Endo-Surgery line of HARMONIC® products represents the cutting edge of advanced surgical devices that help surgeons increase procedural efficiency and improve surgical flow in a wide range of surgical areas. The device uses ultrasonic energy to simultaneously cut and coagulate soft tissue and vessels at much lower temperatures than RF-based devices, resulting in minimal thermal damage to the surrounding tissue. Additionally, since there is no electrical current on the active blade of HARMONIC®, there is minimal risk of electrical energy being transferred to either the patient or the surgeon. HARMONIC® devices have been used in more than five million procedures worldwide.
"HARMONIC WAVE, along with the CONTOUR 40 mm Curved Cutter introduced by Ethicon Endo-Surgery in 2005, represent two innovations in open surgery in the past several years," said Kevin Lobo, president, Ethicon Endo-Surgery, Inc. "At Ethicon Endo-Surgery we're committed to surgical innovations that transform patient care to the surgical community."
HARMONIC WAVE represents the tenth global surgical innovation from Ethicon Endo-Surgery in 2006, which, among others, will be showcased at the American College of Surgeons (ACS) 92nd Annual Clinical Conference in Chicago on October 8-12, 2006.
"Ethicon Endo-Surgery has the newest technology for nearly every procedure being performed by the general surgeon," said John Carlson, worldwide vice president, Research and Development, Ethicon Endo-Surgery, Inc. "In addition, we have completely renovated our entire product portfolio for laparoscopic surgery and our Mammotome Breast Biopsy system now is compatible with all imaging modalities."
2006 Product Launch Highlights
The ECHELON60 is a long Endoscopic Linear Cutter offering the benefits of existing ENDOPATH Endoscopic Linear Cutters, but with a longer, 44 cm shaft length, that can be used in cases where extra length is desired, offering surgeons options for cases involving obese patients.
LIGAMAX5 is a 5 mm endoscopic clip applier providing surgeons with the same clip size as a 10 mm clip applier, but in a 5 mm instrument profile. With the introduction of LIGAMAX5, surgeons don't have to compromise on clip size, allowing them to use smaller trocars. Smaller trocars offer added patient benefits by facilitating a less invasive procedure, improved cosmesis, and reduced risk of herniation.
The HARMONIC ACE36S is the newest addition to the HARMONIC ACE product family. This new product is a 36 cm device able to cut, coagulate, grasp and dissect vessels up to 5 mm in diameter, allowing fewer instrument exchanges for surgeons during minimally invasive procedures, and helping surgeons increase procedural efficiency.
The ENDOPATH XCEL Dilating Tip Trocar is designed for surgeons looking for the benefits of ENDOPATH XCEL trocars, but in a bladed configuration. ENDOPATH XCEL Dilating Tip trocars allow surgeons to focus on the surgical procedure - and the patient - rather than the trocar.
The MAMMOTOME MR Biopsy System is a magnetic resonance imaging (MRI)-guided breast biopsy device to help radiologists accurately diagnose women who are at high risk for breast cancer and who have lesions that cannot be accurately detected with mammography or ultrasound. A procedure with the Mammotome MR Biopsy System involves the single insertion of a needle equipped with a vacuum device into a ¼-inch incision (without open surgery). Under MRI guidance, the device gently vacuums, cuts and partially or completely removes suspicious breast tissue for evaluation. The biopsy incision is small enough that only an adhesive bandage is needed to cover it and no sutures are required. The outpatient procedure can be performed in an MRI suite and typically takes less than an hour. Scarring is minimal.
"The annual number of Ethicon Endo-Surgery new product launches in the U.S. and Global marketplace has grown nearly 4-fold since 2002," said Mr. Lobo. "We're focused on increasing that number even more as the company expands into new and different procedures with new technologies." [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-02-24 17:12
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