Medgadget » Surgery

Five Questions for Dr. Paul Walker of Spectral Diagnostics

Jan Sinnige — Thu, 17 May 2012 18:40:40 +0000

Sepsis is a huge problem, costing billions of dollars and hundreds of thousands of lives a year in the US alone. A Toronto, Canada-based startup Spectral Diagnostics Inc. is developing a promising technology to decrease morbidity and mortality of patients with sepsis. The company’s proprietary technology is integrated into Toraymyxin, a hemoperfusion adsorption column which is highly effective in removing circulating endotoxin from the bloodstream. Furthermore, Spectral Diagnostics has also developed the Endotoxin Activity Assay (EAA) – the only FDA cleared, CE marked rapid diagnostic for endotoxemia. According to a company representative, in 2009 interim results of a Phase II study were published in JAMA demonstrating that “Toraymyxin, when added to conventional therapy, significantly reduced 28-day mortality in patients with severe sepsis and septic shock, compared to patients only receiving conventional therapy. Due to these positive results, that trial was terminated early and a Phase III pivotal multicenter study has been launched in the U.S. and Canada.” To find out more about this technology and its future, we had a chance to conduct an interview with Dr. Paul Walker, President and CEO of Spectral Diagnostics.

Dr. Jan Sinnige, Medgadget: Spectral Diagnostics recently started a phase three randomized controlled trial on Polymyxin B Hemoperfusion. What are the expectations according to the phase two results?

Olive Medical’s HD Rigid Endoscope Provides High Resolution Visualization

Gene Ostrovsky — Mon, 14 May 2012 17:54:49 +0000

Olive Medical out of Salt Lake City, Utah unveiled its HD rigid endoscope for use with the company’s fully HD camera. The endoscope is autoclavable and the company is now offering a rigid endoscope repair program that promises to repair the devices within 48 hours.

Some stated features of the endoscope from the announcement:

A Jet Tour of Northeast Indiana’s Medical Device Hub

Scott Jung — Mon, 14 May 2012 17:12:43 +0000

This past week, Medgadget was invited to take a tour of Northeast Indiana, a region of ten counties surrounding and encompassing the city of Fort Wayne. You might already know about Warsaw, about 30 miles from Fort Wayne, as the headquarters for DePuy, Biomet, Zimmer, and a number of other companies that make the city the leading orthopedic device leader in the world. However, the rest of Northeast Indiana has also been evolving into a thriving medical device manufacturing hub, as labor is available, land is plentiful, and the region is very open and friendly toward the medical device manufacturing industry. In fact, according to the Northeast Indiana Regional Partnership, our host for the two day tour, the region has consistently been a leader in terms of dollars invested and jobs created in the industry. Over two days, we toured a number of different companies and talked to a number of executives about what makes their businesses successful and why they’re at a good place being in Northeast Indiana.

Our first stop was Micropulse, a contract manufacturer of implants and instruments for a number of large medical device clients. Micropulse was originally founded to produce parts for the automotive industry, but in the early 2000′s, founder and CEO Brian Emerick saw his business growing stagnant, and so he switched to medical devices and has never looked back since. What’s interesting about Micropulse is that its facilities are also headquarters to the OrthoVation Center, a new incubator for Emerick’s other medical product ventures. The OrthoVation Center currently is home to four companies: Del Palma Orthopedics, Nanovis, BioSpine, and Sites Medical.

MScore Analyzes Robotic Surgery Simulator Performance

Gene Ostrovsky — Tue, 08 May 2012 13:41:41 +0000

Mimic Technologies, a company that builds the dV-Trainer, a da Vinci surgical robot simulator, recently released a software product to help assess how novice surgeons are using the simulator. The company has been collecting data from experienced surgeons performing various tasks on the simulator, and the MScore application is able to compare a novice user of the dv-Trainer against this data set to provide an overall performance score.

The hope is that with better in-silico training coupled with performance feedback, fewer animals will be sacrificed for this task, and patients will have better skilled surgeons working on them.

Smiths Medical’s ViaValve Safety I.V. Catheter Coming This Summer to U.S.

Gene Ostrovsky — Thu, 26 Apr 2012 17:55:11 +0000

Smiths Medical just got approval from the FDA to introduce its ViaValve Safety I.V. Catheter in the US, a device that promises to help prevent blood exposure and needlestick injuries.

Workings of the device according to Smiths:

Mammotome elite Biopsy System from Devicor Released

Gene Ostrovsky — Wed, 25 Apr 2012 17:29:47 +0000

Devicor Medical Products out of Cincinnati, Ohio is releasing its Mammotome elite Biopsy System for ultrasound-guided biopsies of breasts and axillary lymph nodes. The device features 360-degree needle rotation, allowing the physician to point the aperture at the exact angle required, as well as a removable cannula and a grip that allows for a choice of three different hand positions.

The device received FDA clearance last month and is already CE marked in Europe.

Carestream DRX-Revolution Mobile X-Ray Coming to U.S.

Gene Ostrovsky — Wed, 25 Apr 2012 15:30:18 +0000

Having launched its DRX-Revolution Mobile X-Ray System last September, Carestream has announced that it now has FDA approval to sell the device in the U.S. The DRX-Revolution is a fully mobile X-ray featuring an automatic collapsible column, a wireless DRX detector, and two touch-screens (one at the base and one on the arm) to operate with efficiency and flexibility.

The system already has both European and Canadian approvals.

Caiman Seal and Cut Tools from Aesculap Now Available

Gene Ostrovsky — Fri, 20 Apr 2012 17:01:16 +0000

Aesculap, a subsidiary of B. Braun, has announced it is making available its Caiman line of surgical tools.

The devices feature unique jaw articulation for control and the company’s own algorithm that controls the energy applied to ensure a proper tissue seal.

Siemens and Maquet Partner in Offering Hybrid Diagnostic, Interventional OR

Gene Ostrovsky — Thu, 19 Apr 2012 17:56:05 +0000

Maquet and Siemens have teamed up to combine one of the finest surgical tables on the market, Maquet’s Magnus, with the Artis zeego angiography system from Siemens, to create an offering for hospitals that want to use the same suite for diagnostic imaging as well as for performing surgeries.

The application is primarily intended for the hybrid operating room. A decisive benefit of the combined solution for hospitals is its versatile range of application in the OR: in future, the solution will be used for angiographic imaging as well as for open surgery.
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Beacon Endoscopic’s BNX System for EUS FNA (video)

Gene Ostrovsky — Tue, 10 Apr 2012 16:23:51 +0000

Beacon Endoscopic out of Newton, Massachusetts has developed an interesting new device for endoscopic ultrasound-guided fine needle aspiration (EUS FNA).

The BNX system is aimed at improving efficiency and safety when performing EUS FNA biopsies, and features interchangeable needle sizes. A company representative tells Medgadget that the company’s delivery system is “sold with multiple low cost needles that can be rapidly exchanged through the single delivery system, reducing the down time between needle passes, which improves the clinical workflow. When the needles are removed from the delivery system, they automatically integrate into a safety needle shield, designed to reduce the human errors (manually screwing and un-screwing a needle into a secure position) associated with needle sticks.”