Ob/Gyn Archives

Microline MiSeal Simultaneously Ligates, Welds Soft Tissue

by Gene Ostrovsky on Mar 31, 2011 •

cyrd11wa Microline MiSeal Simultaneously Ligates, Welds Soft Tissue
Microline Surgical (Beverly, MA) has released its new MiSeal Reposable Thermal Ligating 37kxpd3w Microline MiSeal Simultaneously Ligates, Welds Soft TissueSystem. The device seals and cuts soft tissue in one stroke utilizing the company’s proprietary heat and pressure welding technology.
From the press release:

MiSeal is comprised of a reusable handle and disposable tips, combining the precision of a fully disposable instrument with the economic benefits and quality of a fully reusable handpiece. Unlike conventional products that use monopolar, bipolar or ultrasonic energy as modes of operation, MiSeal features proprietary tissue welding technology, which employs direct thermal energy and focused pressure to create a high-integrity
seal and a clean division, while minimizing the risk of collateral tissue damage.
The 5mm MiSeal features heating elements at the distal tip, which are activated by a finger switch located on the handpiece of the device. The instrument’s dual-action jaw can be used as a dissector or grasper, minimizing instrument exchanges and improving efficiency in the operating room. MiSeal is powered by the Universal Power Supply (UPS), a compact, three-pound, reusable power source that can hang from an IV pole or sit on a tabletop, offering ease of set-up and use, which can reduce procedure and clean-up time.

Press release: Microline Surgical launches MiSeal™ Reposable Thermal Ligating System at SAGES 2011 Annual Meeting
Product page: MiSeal Reposable Thermal Ligating System

Cardiac Surgery / Ob/Gyn / Orthopedic Surgery / Surgery / Thoracic Surgery / Urology / Vascular Surgery

Simquest Open-Incision Surgical Simulation (updated)

by Wouter Stomp on Mar 29, 2011
Simquest Open-Incision Surgical Simulation (updated)

Update: An earlier version of this post used images from an earlier prototype and incorrectly stated the partnering company in the project.
There are quite a few laparoscopic surgery simulators out there, but curiously, open surgery is still completely learned by practicing on live subjects (whether it be patients or animals). Simquest (Silver Spring, Maryland) is changing that by releasing the first open-incision surgical sim. The company worked with Novint (Albuquerque, New Mexico) to bring haptics to the simulator, providing force feedback simulation in addition to 3D graphics. Because of the larger surgical field and the number of possible actions for open surgery this simulator was significantly more difficult to develop than laparoscopic simulators.

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Ob/Gyn / Oncology

Cevira, A Medical Device/Drug Combination, Proving Itself Against HPV

by Gene Ostrovsky on Mar 15, 2011
Cevira, A Medical Device/Drug Combination, Proving Itself Against HPV

Cevira, a photodynamic therapy device and hexaminolevulinate ointment combination product from Photocure (Oslo, Norway), is moving right along Phase II clinical trials for the treatment of Human Papilloma Virus (HPV). The package is inserted into a woman’s cervix where it stays active for an entire day, applying both light and ointment to the affected tissue. The device, which was developed with help from Sagentia (Cambridge, Massachusetts), has received FDA approval to continue with Phase II trials.

The Cevira device contains a LED light source that in combination with a medicinal product initiates a photochemical reaction in exposed tissue. The fully integrated single-use device is easily administered by a trained gynaecologist or colposcopist and is then left in place on the cervix up to 24 hours, during which time the patient is able to leave the hospital and continue with her daily activities, before removing and disposing of the device herself.

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Ob/Gyn / Surgery / Thoracic Surgery / Urology / Vascular Surgery

Cardica’s New Microcutter Devices Do Double Duty as Cutters and Staplers; Require Less Frequent Reloading

by Smit Shah on Mar 7, 2011
Cardica's New Microcutter Devices Do Double Duty as Cutters and Staplers; Require Less Frequent Reloading

We’re no strangers to surgical staplers here at Medgadget, but Cardica, Inc. claims its upcoming Microcutter line of staplers will provide significant improvements over existing options. The new staplers will double as surgical cutters and will allow surgeons to make multiple staple deployments without needing to reload with a fresh cartridge. Additionally, the company claims that Microcutter devices will have a smaller diameter than currently available surgical staplers, which will allow for less-invasive procedures. Cardica has just received CE marking for the Microcutter line, and plans to begin the FDA 510(k) approval process later this year.
From the press release:

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Ob/Gyn

First Device to Prevent Hemorrhoids During Vaginal Birth Given FDA Approval

by Gene Ostrovsky on Feb 28, 2011
First Device to Prevent Hemorrhoids During Vaginal Birth Given FDA Approval

Natural child birth is famous for the vaginal pain women experience, but it ain’t no joke that the anus is also subject to a good deal of force in the process. That is why around a quarter of vaginal births result in hemorrhoids, something you really don’t want to be dealing with when you just had a baby. Nurses will often use their hand to counteract the pressure on the anus, but this can be extremely tiring as labor can take hours. David Blurton, a medical device industry veteran, became acutely aware of the problem when his wife gave birth. Confounded by the fact that there was no available solution to the issue, he developed the Hem-Avert device that effectively reproduces the actions of the nurse’s hand in preventing hemorrhoids.
Plexus Biomedical out of Oakland, TN, the company started by Blurton, has received FDA clearance for the Hem-Avert. This followed a clinical study that showed that the new device prevented hemorrhoids in all of the women that wore it during labor compared with a 25% hemorrhoid rate in the control group.

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Ob/Gyn / Surgery / Urology

Covidien’s LigaSure Curved, Small Jaw, Open Sealer/Divider Cleared in US

by Gene Ostrovsky on Feb 18, 2011
Covidien's LigaSure Curved, Small Jaw, Open Sealer/Divider Cleared in US

Covidien has received 510(k) clearance from the FDA for the firm’s LigaSure Curved, Small Jaw, Open Sealer/Divider, a device used in general surgery. It will be available in the US later this quarter.

The LigaSure Curved, Small Jaw, Open Sealer/Divider, the newest addition to the LigaSure family of advanced surgical cutting/sealing devices, provides an integrated cutting mechanism independent of sealing, leaving the critical cutting decisions in the hands of the surgeon. Its multi-functional design also provides for blunt dissection and an enhanced, more efficient experience for the surgeon, especially in confined surgical spaces. A primary feature of this new LigaSure device is a low-temperature profile and minimal thermal spread to surrounding tissues.

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Ob/Gyn / Radiology / Surgery

FDA Approves Hologic’s Selenia Dimensions 3-D System

by Smit Shah on Feb 11, 2011
FDA Approves Hologic's Selenia Dimensions 3-D System

Bedford, MA based Hologic, Inc. has announced FDA approval of its Selenia Dimensions 3-D system for three dimensional breast imaging. The system was recommended for approval by the FDA’s Radiological Devices Panel this past September, and is now the first 3D breast imaging solution to be FDA approved. Hologic also announced that existing Dimensions 2-D systems can be upgraded to incorporate the new 3D functionality, which uses multiple X-ray views to produce a 3D representation of the patient’s breast.
From the press release:

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Net News / Ob/Gyn / Surgery / Urology

Kinect 3D Gaming Camera Used to Control da Vinci Surgical Robot

by Gene Ostrovsky on Feb 10, 2011

Pushing further the possibilities of what one can do with the $150 Microsoft’s Kinect 3D controller, engineers from Johns Hopkins University managed to hook up a Kinect as an interface for a da Vinci surgical robot. See for yourself:

Nicolas Padoy, from the CIRL laboratory, has demonstrated in a youtube video how to perform a needle insertion as well as other fine manipulation tasks using a kinect and a surgical da Vinci robot used here for non-clinical research.

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Anesthesiology / Critical Care / Emergency Medicine / Medicine / Net News / Ob/Gyn / Pediatrics / Surgery / Urology / Vascular Surgery

Mobisante’s MobiUS Smartphone Ultrasound Receives FDA 510(k) Clearance

by Scott Jung on Feb 7, 2011
Mobisante's MobiUS Smartphone Ultrasound Receives FDA 510(k) Clearance

Cellphones have come a long way with the rise of the smartphone. What used to be simply a means of making phone calls remotely, now is the way by which we can send emails, text messages, photos, and…acquire fetal images!
You can thank Redmond, Washington-based Mobisante for that last one, because it has announced that its MobiUS ultrasound imaging system has received FDA approval to be marketed in the United States.

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