Singapore – March 5, 2009– Dornier MedTech introduces the new high powered Medilas D UroBeam laser at UroFair 2009 on March 5, 2009 in Singapore. The advanced technology of the UroBeam offers a unique 940nm wavelength and 250 watts of power which excels in making this laser ideal for treating Benign Prostatic Hyperplasia (BPH) with minimal invasiveness and reduced side effects. For thousands of Asian patients suffering from BPH yearly, this state-of-the-art system represents a safe and effective solution to improve their quality of life.

With the highest powered BPH laser in the market, Dornier’s UroBeam offers physicians greater treatment flexibility for effectively treating BPH.  “The 940nm wavelength absorption characteristics targeting both water and hemoglobin optimize this approach and remove the limitations experienced by other devices.” notes Dr. Thomas Bayer, Assistant Director from the Department of Urology of Kempten Hospital, Germany.

In addition, the Medilas D UroBeam laser includes the proprietary Lightguide Protection System (LPS), which automatically disables the laser in the event of excessive heat at the fiber tip. Furthermore, the system supports a special fibertom™ mode that keeps the tip temperature constant by automatically controlling the laser output power. Both new features mark a significant advancement in terms of patient’s safety and are hallmarks of Dornier’s commitment towards treatment excellence.

With the UroBeam complementing Dornier’s existing portfolio of urology product, it provides an example of the continuous innovation in urology that Dornier is committed to providing patients and physicians alike. Integrating Dornier’s advanced laser technology and valued physician’s feedback, the Medilas D UroBeam offer patients a reduction in their hospital stay whilst having significant improvements in both patient safety and efficacy in the treatment of BPH.

“Since its initial launch in September 2008 at the German Urological Association (DGU) conference in Stuttgart, Germany, Dornier’s Medilas D UroBeam has generated much interest with its innovative features”, said Mr. Dave Eng Keen Huat, President & CEO of Dornier MedTech Group. Mayumana Healthcare believes this technology will change BPH treatments. Dornier has shown superior quality and service over the last years, I think this product will be a great succes., also in The Benelux…  For more info goto www.dornier.com or stay tuned…..

Bart Verleg

Percsys Accordion debute in Academisch Ziekenhuis Utrecht

After a short introduction Mayumana Healthcare has done a first case in The Netherlands with the Percsys Accordion. The stone management device was introduced very easy and was positioned behind a very large stone in the ureter. Without this device the danger was that the stone would fragement during laser treatment and would get lost in the kidney. After the postioning, a 100 Watt laser was used to fragment the stone.

Because of the Accordion it was very easy and super fast to crush the stone. Mayumana Healthcare believes this device will change stone management procedures. For information about the product, please go to www.mayumana-healthcare.com

Stone Management disposable

The new PercSys Accordion(R) Stone Management Device, an advanced microcatheter that features a proprietary film occlusion to prevent stone migration and facilitate fragment removal during endoscopic lithotripsy procedures. Designed for aiding in the treatment of kidney stones in the ureter, the Accordion device combines the utility of multiple endoscopic stone management tools into a single device, and is designed to simplify and shorten endoscopic lithotripsy procedures.

“The Accordion Stone Management Device combines the benefits of a device for blocking stone migration with a basket for removing stone fragments,” said Richard David M.D., Associate Clinical Professor of Urology, David Geffen School of Medicine, University of California, Los Angeles. “Most importantly, it is easy to deploy even around large fragments, eliminating the challenges that occur when a fragment cannot be released from a basket. For these reasons, the Accordion is a valuable new tool with potential for routine use in lithotripsy procedures.”

The key feature of the Accordion device is a multi-fold film occlusion that is deployed at its distal end. Once formed, the film occlusion conforms to and fills the ureter in order to prevent retrograde migration of stone fragments into the kidney. During stone fragmentation, the Accordion device facilitates distal rinsing of smaller fragments to keep the field of view clear. Following fragmentation, the device can easily sweep larger fragments into the bladder or a ureteral access sheath, thereby eliminating tedious and time-consuming serial basketing of individual fragments. The robust occlusion film is able to withstand inadvertent contact with holmium laser and intracorporeal lithotripter energy.

The Accordion device is easy to place due to a hydrophilic coating that allows it to track past the stone like a guidewire. In addition, the device features radiopaque markers that enable monitoring of advancement and deployment using fluoroscopic visualization. When required, the Accordion device’s telescoping design enables the film occlusion to release easily from intact stones and large fragments.

About PercSys

Percutaneous Systems, Inc. (PercSys) is a Mountain View, Calif.-based medical device company focused on developing interventional devices for the minimally invasive treatment of urologic and urogynecologic disorders. The company’s goal is to develop devices for use in hospital, office and clinic environments that make urologic and endoscopic procedures easier, less traumatic, and more effective therapeutically. In this way, PercSys seeks to change the practice of urology to benefit physicians, patients and payors. For more information about PercSys and the PercSys Accordion(R) Stone Management Device, please visit: www.PercSys.com. This product is being distributed by Mayumana Healthcare in The Netherlands.   www.mayumana-healthcare.com

Radio Frequency Ablation– How Does it Work?

Radiofrequency is a type of electrical energy that has been used in medical procedures for decades. At the most basic level, this electrical energy is used to create heat. The heat is created in a specific location, at a specific temperature, for a specific period of time, and ultimately results in the death of unwanted tissue.

During a radiofrequency procedure, an ablation probe is placed directly into the target tissue. An array of several small, curved electrodes are deployed from the end of the probe into the tissue. The generator is turned on and target temperatures are input. The radiofrequency energy flows through the electrodes, causing ionic agitation, and therefore friction, in the nearby tissue. This friction creates heat, and once sufficient temperatures have been reached, the heat kills the target tissue within a few minutes. Thermocouples (tiny thermometers) incorporated into the tips of the electrodes allow continuous monitoring of tissue temperatures, and power is automatically adjusted so that the target temperatures remain constant. Ultrasound is typically used to monitor the treatment process.

Heat is a very effective means of killing tissue. As tissue temperature rises above 113° F (50° C), protein is permanently damaged and cell membranes fuse. The process is rapid, typically requiring less than 10-15 minutes exposure time for a 3 cm ablation Depending on the power applied and the resistance of the tissues, heat decreases rapidly at a specific distance from the electrode tip, limiting the ablation size. The size of the ablated area is determined largely by the size of the probe, the temperature of the tissue, and the duration of time the energy is applied. There is a sharp boundary between dead tissue and unaffected surrounding tissue. Thus unwanted tissue can be ablated without much sacrifice of surrounding normal tissue. 

What is an RF Procedure Like?

Your physician can tell you what to expect before and after the procedure. There are several different ways that a RF procedure may be performed, and each has different benefits, limitations, and applicability. Your physician can determine which is most suitable for you. One option is a percutaneous approach, in which the electrode is inserted through the skin to the desired location. The physician usually uses ultrasound to guide the needle to the right location. This is the least invasive way that RF is performed. General anesthesia is usually not necessary, but typically the patient is sedated. Often the patient is able to go home the same day If general anesthesia is not used, some discomfort or pain may be felt while the area is being ablated. 

Options

Another option is a laparoscopic approach. With this approach, the surgeon makes a few small incisions in the abdomen, through which the necessary instruments are passed in order to treat the target tissue. This is also a minimally invasive approach, although general anesthesia is necessary. Patients typically go home the next day. One advantage of this approach is that intraoperative ultrasound can be used, which may result in more accurate location and visualization of the target tissue.

A third option is the open approach. This is what most people probably think of when they think of an operation. An incision is made in the area to be treated, and the surgeon can directly visualize the procedure. General anesthesia is necessary, and the recovery period is a bit longer. Patients may experience a slight fever for two or three days after the procedure. Physicians often allow the fever to resolve without intervention. RF ablation procedures have a relatively low rate of complications (~ 3.6%). Most of the complications are considered minor. The following are the complications associated with this procedure: infection (abscess), bleeding, collapse of the lung, abnormal heart rhythms, and skin burn.

Development is going so fast in the digital world, that the question many times rises, what is better: CCD or CMOS sensors? Therefore I was doing some investegation and found an interesting article about the actual differences. 

Can anybody tell me which one will stay alive?

The technologies and the markets that use them continue to mature, but the comparison is still a lot like apples vs. oranges: they can both be good for you. 

CCD (charge coupled device) and CMOS (complementary metal oxide semiconductor) image sensors are two different technologies for capturing images digitally. Each has unique strengths and weaknesses giving advantages in different applications. Neither is categorically superior to the other, although vendors selling only one technology have usually claimed otherwise. In the last five years much has changed with both technologies, and many projections regarding the demise or ascendence of either have been proved false. The current situation and outlook for both technologies is vibrant, but a new framework exists for considering the relative strengths and opportunities of CCD and CMOS imagers.

Both types of imagers convert light into electric charge and process it into electronic signals. In a CCD sensor, every pixel’s charge is transferred through a very limited number of output nodes (often just one) to be converted to voltage, buffered, and sent off-chip as an analog signal. All of the pixel can be devoted to light capture, and the output’s uniformity (a key factor in image quality) is high. In a CMOS sensor, each pixel has its own charge-to-voltage conversion, and the sensor often also includes amplifiers, noise-correction, and digitization circuits, so that the chip outputs digital bits. These other functions increase the design complexity and reduce the area available for light capture. With each pixel doing its own conversion, uniformity is lower. But the chip can be built to require less off-chip circuitry for basic operation. 

CCDs and CMOS imagers were both invented in the late 1960s and 1970s. CCD became dominant, primarily because they gave far superior images with the fabrication technology available. CMOS image sensors required more uniformity and smaller features than silicon wafer foundries could deliver at the time. Not until the 1990s did lithography develop to the point that designers could begin making a case for CMOS imagers again. Renewed interest in CMOS was based on expectations of lowered power consumption, camera-on-a-chip integration, and lowered fabrication costs from the reuse of mainstream logic and memory device fabrication. While all of these benefits are possible in theory, achieving them in practice while simultaneously delivering high image quality has taken far more time, money, and process adaptation than original projections suggested 

Both CCDs and CMOS imagers can offer excellent imaging performance when designed properly. CCDs have traditionally provided the performance benchmarks in the photographic, scientific, and industrial applications that demand the highest image quality (as measured in quantum efficiency and noise) at the expense of system size. CMOS imagers offer more integration (more functions on the chip), lower power dissipation (at the chip level), and the possibility of smaller system size, but they have often required tradeoffs between image quality and device cost. Today there is no clear line dividing the types of applications each can serve. CMOS designers have devoted intense effort to achieving high image quality, while CCD designers have lowered their power requirements and pixel sizes. As a result, you can find CCDs in low-cost low-power cellphone cameras and CMOS sensors in high-performance professional and industrial cameras, directly contradicting the early stereotypes. It is worth noting that the producers succeeding with “crossovers” have almost always been established players with years of deep experience in both technologies.

Costs are similar at the chip level. Early CMOS proponents claimed CMOS imagers would be much cheaper because they could be produced on the same high-volume wafer processing lines as mainstream logic or memory chips. This has not been the case. The accommodations required for good imaging perfomance have required CMOS designers to iteratively develop specialized, optimized, lower-volume mixed-signal fabrication processes–very much like those used for CCDs. Proving out these processes at successively smaller lithography nodes (0.35um, 0.25um, 0.18um…) has been slow and expensive; those with a captive foundry have an advantage because they can better maintain the attention of the process engineers.

CMOS cameras may require fewer components and less power, but they still generally require companion chips to optimize image quality, increasing cost and reducing the advantage they gain from lower power consumption. CCD devices are less complex than CMOS, so they cost less to design. CCD fabrication processes also tend to be more mature and optimized; in general, it will cost less (in both design and fabrication) to yield a CCD than a CMOS imager for a specific high-performance application. However, wafer size can be a dominating influence on device cost; the larger the wafer, the more devices it can yield, and the lower the cost per device. 200mm is fairly common for third-party CMOS foundries while third-party CCD foundries tend to offer 150mm. Captive foundries use 150mm, 200mm, and 300mm production for both CCD and CMOS.

The larger issue around pricing is sustainability. Since many CMOS start-ups pursued high-volume, commodity applications from a small base of business, they priced below costs to win business. For some, the risk paid off and their volumes provided enough margin for viability. But others had to raise their prices, while still others went out of business entirely. High-risk startups can be interesting to venture capitalists, but imager customers require long-term stability and support.

While cost advantages have been difficult to realize and on-chip integration has been slow to arrive, speed is one area where CMOS imagers can demonstrate considerable strength because of the relative ease of parallel output structures. This gives them great potential in industrial applications.

CCDs and CMOS will remain complementary. The choice continues to depend on the application and the vendor more than the technology. DALSA’s approach is “technology-neutral”: we are one of the few vendors able to offer real solutions with both CCDs and CMOS.

Technological advancements in minimally invasive surgery are evolving and are expected to rapidly drive this new growth sector over the next decade; the move away from historical and conventional open and invasive surgical procedures in Europe is evident. Other areas such as increased use of disposable surgical instruments; biologic, endoscopic, and laparoscopic products; electrosurgery; laser surgical techniques; and surgical robotics will all have a great impact on surgical procedures.
All new advances are scrutinized closely by both healthcare technology assessment bodies across France, Germany, Italy, Spain, and the U.K. to determine if new technology from commercial companies offers value-added benefits to both the patient and the payee before reimbursement code listing is approved and assigned. The surgical revolution and significant benefits promised by minimally invasive surgery have until recently been undermined and limited to simpler procedures, such as gallbladder removal.
For some surgeons, minimally invasive surgery limits their precision and dexterity, and effectively prevents its natural evolution and widespread acceptance in more technically complex procedures; surgeons have found that viewing procedures on a video monitor and operating with long, slender “chopstick” instruments can be difficult and uncomfortable. This situation within the surgical procedures market is seen to been changing, however, with the emergence during the past 18 months of a far wider scope of surgical procedures being carried out using minimally invasive techniques, and improved technology that is more user friendly and more comfortable for surgeons to use.
Minimally invasive surgery is being utilized in the operating room and day surgery is becoming commonplace worldwide. Future trends indicate that one of the most significant factors with surgical procedures in the operating room will be the need for preoperative rehearsal. This is viewed as a major factor in improving surgical procedure outcomes as well as:
• improving patient recovery time and clinical outcome;
• improving the time frame in which hospitals discharge patients;
• reducing hospital bed occupancy rates; and,
• reducing patient trauma.

Another factor that is becoming highly visible is medical litigation due to medical malpractice or errors; this has become evident in most countries with developed healthcare infrastructures. Thus, preoperative preparation is expected to be of greater significance in the future in order to reduce the risks associated with surgical procedures.

Minimally invasive surgery continues to develop and become a suitable alternative in the surgical management of gynecologic malignancies. Intuitively, patient satisfaction has helped to drive the discipline of minimally invasive surgery. Smaller incisions, less postoperative pain, and shorter hospital stays are welcomed by women suffering from gynecologic cancers. More importantly, though, the science has kept up with innovative minimally invasive techniques [42].

Minimally invasive surgery has been shown to be safe and feasible while treating patients with the same efficacy as traditional open procedures. This, above all else, will help guarantee minimally invasive surgery as an acceptable approach in treating gynecologic malignancies.

For the entire article go to: http://theoncologist.alphamedpress.org/cgi/content/full/11/8/895
Alan C. Schlaerth, Nadeem R. Abu-Rustum
Gynecology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York, USA

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I personally believe laparoscopic surgery is perfect for today’s surgery. One of the problems with laparoscopic surgery though, or newer forms of surgery like robot and single port surgery and NOTES (Natural Orifice Translumenal Endoscopic Surgery) is that these cases in the beginning are time consuming. The physicians or better yet the persons with the buckets of gold do not want these procedures to be a ‘foreveroscopy’!

The ‘Nintendo generation’ physicians is easier convinced to use new minimal invasive procedural driven laparoscopic products, older generations have some bottlenecks.

For that reason the older generation of physicians and management choose traditional procedures and products to perform the surgery. Is there a difference in quality between hospitals because of the different approaches of surgery? The answer is obvious, however how can this be changed? In Europe there is so much difference in quality of surgery, safety and success, where do you start? The physicians are traveling more and more and learn in other countries what is possible. Take the gynecologic cancers, new products and training can make the surgery go more smooth, with more success for the patient and also the hospital. The problem is though, that when the physicians go home, they face financial problems, others are not convinced because of new techniques and they are back where they started. This can create a snowball effect, physicians leave the home country to perform surgery somewhere else.

I believe more and more work groups should be formed and more influence should be involved from a European level to train physicians in minimally invasive surgery in for instance East-Europa. By the way, one of the bottlenecks in these countries is the problems of disposable usage in comparison to re-usable. There are many pro’s and cons for both, I will get back to you on that.

Do you have any ideas how to spread the new techniques on a European level with a financial system, so that everybody can use the technology?

B.V.

Integration and merging of companies is a sensitive undertaking. If it goes to fast, you loose momentum, if it goes to slow you also loose power. Integration also means; taking time to learn, adjust only at the proper time and respect both cultures of the companies involved.

One culture always survives and usually it is the strongest one inside one of the companies. Bringing a culture to another company will always cause problems. Bottlenecks between people, organizational differences and many more issues are subject to a lot of collateral damage. Many mergers and integration fail because of this. However if the proper people act smart and think carefull about the future on the long term, there is a good chance it will work. The ‘new’ company’ needs the right people, who can be objective and have a helicopter view.  Pride and past plans need to be cleared in everybody’s head in order to move forward.

With the proper management, sales and marketing structure the organization will gain more power, more possibilities and a stronger market position. R&D, salespeople and product managers with long experience need to be protected if they want to stay on board. They are the legacy and can be part of the foundation of the new structure. However, new people with a bright and fresh view are also needed to be the bridge between the two companies and to help the company to go towards the right direction.

Which medical devices companies have merged in the past? If you have examples, comment on this article.

Regards,

Bart Verleg

Companies are being bought all the time, also in the medical field. Take the Olympus Gyrus ACMI deal. Because of this aquisition the ‘new company’ is very strong. In ENT almost as strong as Medtronic, bearing in mind that Gyrus ACMI was already the number two.

Where does this leave Storz and Wolff? Also in the gynecology and uology Gyrus ACMI is going strong and less players to fight. I would say former Tyco will have to watch out now, since general surgery will most probably be the next step for Olympus to grow the business.

Other companies will have to be dynamic and flexible to stay alive. More important, they will have to feed the market with new products in order to make a future for themselves on the long term. I would say, this will give also new oppurtunities for other companies to join this shallow sea. Though only if they can fill certain wholes or come up with new promising high end technology.

It is starting to look in this industry like the supermarket war that has been going on for some years. All the small shops closed, all the big supermarkets got bigger and stronger. The marketplace has changed a lot through years.

Many medical companies do business through an extensive and reliable distributor network, this network is getting smaller and smaller, because more and more companies are starting a direct organisation in all corners of the European area. I think that the dealers specialized in medical devices have to make a game plan for the following years, if they want to keep on generating business because the chance of loosing a succesfull productline is more likely to happen.

Bart Verleg

New trends are arriving in urology concerning washing and disinfecting instruments. For some reason hospitals are adapting the process they use for semi-rigid scope for flexible scopes. Hospitals like to wash the scope automatic and then sterilize it in a plasma machine. However, this is just a trend and not everybody is following this trend. At this moment almost each country has its own rules for washing and disinfecting. This is giving big problems to the manufacturers of scopes. They are trying to make protocols, but with so many trends, it is very hard to chase them all. Then the question rises: how clean, disinfected and sterile will the flexible scope be after the washing process? Because of the rather small lumen of flexible ureteroscopes it is very hard to proper clean them. So basically there still is a risk of decontamination of the scope, even though it was washed properly. In the Netherlands organisations within the hospitals are talking about the possibilities to get a uniform protocol to wash flexibles. In my opinion, there is still a very long road ahead of us. Hopefully soon there will be a way to properly wash, disinfect and sterilize the scope, without damaging the scope on a short notice.  To be continued…