Frequently Asked Questions

At the present time, Pensar Medical manufactures and sells one negative pressure therapy system, the WoundPro NPWT System. We also manufacture and sell all the related products necessary for negative pressure wound therapy, namely dressing kits and collection canisters. In addition we offer bridge kit systems and a patent pending Y-Connector to treat two wounds with one control unit.

The WoundPro Negative Pressure Wound Therapy System is our most popular unit at the present time.

The WoundPro is one of the most powerful units in the market today. The WoundPro offers 8 lpm of suction flow. The pressure settings range from 0mmHg to -200mmHg depending upon the physician’s discretion.

No. However the unit does remember the last pressure setting used by the unit prior to it being powered down. At Pensar Medical we know that no one pressure or therapy mode is right for every patient, allowing the physician or caregiver to choose the best therapy possible for each individual patient. The Control Unit will not influence that decision with automatic “defaults” when the unit is powered on.
Because the WoundPro will remember that last setting before powering off as a convenience to the user, you do not have to reprogram the unit for the same patient every time the unit is turned off for any reason (e.g. dressing or canister changes).

Absolutely. The WoundPro is designed to allow the user to change therapy modes, times and pressures, all at the touch of a button on the control panel.

Yes. The WoundPro was one of the first units to provide all three negative pressure therapies. It not only provides continuous therapy but also both intermittent and variable intermittent therapy.

Yes. The WoundPro provides not only an alarm when a canister is close to capacity and will need to be replaced soon, but also shuts down the pump when the canister becomes full.

A one-way valve is unnecessary because once the fluid has reached the collection canister, all exudate is then trapped in the canister and cannot flow back to the patient.
It is virtually impossible for fluid to flow back towards the patient if the unit is set in either the continuous or variable intermittent modes as negative pressure is always being applied at some level.
Should a line blockage situation occur, an alarm will sound, alerting the user of this condition, further preventing any fluid going back toward the patient.

When fully charged the WoundPro is designed to last the industry standard of 24 hours (at the very least), assuming there is not a gross leak in the dressing application. While the user’s assurance that the charge will last 24 hours as a bare minimum, new batteries on the WoundPro have lasted as long as 72 hours in testing in our lab.

The WoundPro Control Unit weighs 3.8 lbs when the canister is empty. Since the introduction of the WoundPro a couple of years ago, it’s clear that the market is asking for smaller, more portable units. However most smaller units come with smaller pumps (a reduction in power) and smaller batteries (shorter battery life).

Pensar Medical offers our ProFoam® hydrophobic (reticulated) foam dressings in a variety of sizes to accommodate wounds of any size.
The dressing is placed directly at the wound site to facilitate the application negative pressure. The pore structure of our ProFoam Dressings helps to promote healing and tissue granulation. The open cell structure of the foam creates a filter enabling exudate to flow through to the canister, while its pores are small enough to prevent in-growth into the foam. The WoundPro ProFoam Dressing:

• Adapts to the contours of deep and irregularly shaped wounds
• Helps provide uniform distribution of negative pressure at the wound site
• Helps facilitate exudate and infectious material removal through a hydrophobic pore structure
• Compresses to less than half its size under negative pressure to help draw wound edges together and induces macrostrain and microstrain

As a general rule, dressings should be changed approximately every 48 to 72 hours, but no less than 3 times per week. This guideline normally applies to non-infected wounds. Monitoring of the wound must be performed on a regular basis.
Infected wounds must be monitored more often. The dressing change intervals should be based upon the wound’s progress and condition, which can result in more frequent dressing changes.
The frequency of the dressing changes can be adjusted by the clinician as appropriate.

Yes. By applying a Y-Connector, the caregiver can treat more than one wound at the same time using one WoundPro Control Unit. We would recommend treating a maximum of two wounds simultaneously with one control unit. Attempting to treat more than two wounds can be difficult as:

• One pump can only be set to one pressure (so both wounds will be treated at the same pressure)
• Each wound should be of the same etiology
• More dressings and more tube connections result in a higher chance for leaks, which the unit may not be able to compensate for to provide adequate therapy

Typically, white hydrophilic foam is used in undermined areas, and can be obtained as a separate accessory. It is important that the hydrophilic foam you use have the following characteristics:

• Good absorption qualities
• Low swelling, so the foam doesn’t pull away from the wound
• Superior tensile strength (does not tear easily) during removal of the foam from the tunnel

Negative Pressure Therapy is contraindicated for use with non-enteric and unexplored fistulas. If considering the use of Negative Pressure Therapy involving enteric fistula, it is recommended to seek support from an expert clinician. Negative Pressure Therapy is not recommended or designed for fistula effluent management or containment, but as an aid to wound healing in and around the fistula.

Tendons, ligaments and nerves should be protected to avoid direct contact with Negative Pressure Dressings, and can be covered with natural tissue or meshed non-adherent porous material or bioengineered tissue to help minimize risk of desiccation or injury. Bone may be protected with a single layer of a non-adherent interface.

Negative Pressure Therapy is contraindicated for untreated osteomyelitis. If a clinician decides to use Negative Pressure Therapy for other infected wounds, then they must be monitored often and very closely, and dressings may need to be changed more often than 48 to 72 hours in order to assess the wound and patient condition. The dressing change intervals should be based on a continuing evaluation of wound condition and the patient’s clinical presentation, rather than a fixed schedule.

The Pensar WoundPro Negative Pressure System can be either purchased or rented and is typically billed to the patient’s insurance depending on eligibility and coverage through our nationwide distributor network. Dressings and dressing kits are available for purchase and supplies can be replenished as needed, based on clinical evaluation by healthcare professionals.

The only similarities between the MicroDoc and the PICO are that they both come in a box!!!  You wouldn’t compare a Lamborghini to a Volkswagen even though they are both cars, would you?

The PICO pump is a very unsophisticated unit with only one pressure setting, 80mmHg.  And the acceptable amount of error is +/- 20mmHg.  Simply put that means that the actual pressure to your wound can be anywhere between 60 and 100mmHg at any given time.  Admittedly, while this wide pressure swing is probably not dangerous to your patient, it certainly does not speak to the accuracy of their machine and the amount of therapy afforded to the patient.  The MicroDoc can be set to 3 distinctly difference pressure settings and our tolerances are very tight compared to the PICO.  The 20mmHg “acceptable” tolerance for the PICO represents a 25% deviation from the expected pressure setting of 80mmHg.  The MicroDoc tolerance is less than 3% on all three of its settings.

Secondly and most importantly, the biggest difference between the two systems is the dressing, which is the most critical part of the system as it interacts directly with the patient’s wound.  The PICO, like every other disposable system on the market, employs a hydrophilic bandage to the wound.  Once the negative pressure has sent exudate towards the dressing, the dressing relies exclusively on evaporation to ensure that the removed exudate does not remain in direct contact with the wound.  Sadly, evaporation is never quite good enough and the wet dressing almost always results in maceration of the wound bed and the surrounding healthy skin.

The MicroDoc employs an advanced and self-adapting dressing that was designed first as a standalone product.  When NOT hooked up to our MicroDoc Control Unit the Enluxtra dressing is used every day in many healthcare facilities on its own.  It ability to “self-adapt” and remove and absorb exudate away from the wound and collect inside the dressing WHILE keeping a wound moist is truly remarkable.  Coupled with our MicroDoc, the negative pressure therapy helps to maximize surface area contact in the wound enabling the Enluxtra to perform at a level it cannot perform at on its own.  No other system on the market can make these claims.

Simply put, you don’t. That is why our system and with every other system on the market today you need to periodically check to make sure the pump is functioning normally and take a visual look at your wound dressing to visually confirm you have a tight seal around the dressing. Most every disposable system on the market today only has visual notifications to let the user know it may not be working properly. And while a couple systems may offer an audible alarm, their volume levels are so faint they are very difficult to hear.

HOWEVER, as described above, the MicroDoc is the ONLY system on the market that uses the Enlxutra dressing.  Should the MicroDoc stop functioning properly (because of a clogged line or a vacuum leak), the Enluxtra keeps doing what it has done for years as a standalone and non-powered dressing:

• Offering the highest levels of absorbency
• Built in self-additivity by keeping the wound moist for better healing
  • Enluxtra vertically absorbs and locks in the exudate from exuding wound zones, while at the same time adaptively hydrating dry wound zones with the help of embedded hydrogel.
• Selective wound cleansing
  • Enluxtra is able to gradually, painlessly and non-traumatically remove slough, necrotic tissue and other non-viable and pro-inflammatory components from the wound bed, as well as reduce wound drainage and odor without use of any enzymatic topical agents.

As with any other disposable system, the most obvious answer is to purchase another MicroDoc System to prolong the therapy for another 7 to 10 days.  However, we believe that in many cases healing may be at a point where an Enluxtra dressing alone, may be all the wound may need to fully heal saving you the expense of having to purchase an entirely new system.  Your healthcare professional will know best how to proceed.

A quick check of the unit and dressing will assure the user that the unit is working as it should.   Perhaps the easier way to determine the unit is working properly is to take a quick glance at the control unit.  The chosen pressure light will remain on and constant if the unit is working properly.  Secondly, we have all grown used to seeing what a traditional negative pressure dressing looks like when the unit is functionally normally.  The big foam dressing is pulled down tight and has that “raisin” appearance.  With the MicroDoc, a quick check of the outer drape around the Enluxtra dressing will show it is very tight and snug around the outer perimeter of the dressing.  See images to the right.

Absolutely not.  As a battery SAVING feature, the only light that will stay on after a short period will be the pressure setting light.  Whenever the unit is first powered ON, the GREEN battery light will illuminate and remain on for a short while.  It will go out however to save the life of the batteries.  When there is approximately two days of battery life remaining, the battery light will illuminate in an AMBER color.   When the battery light shines RED the unit is about to stop working.

We will be the first to agree that having a premade and stick-on dressing is very easy to apply.  HOWEVER, with premade dressings you are locked into that one size, and when has one size fits all EVER fit correctly?  And while the others offer different sized dressings, that means placing another order and waiting for dressings to arrive, when you have a patient that needs therapy now.
While it requires a bit more effort, the ability to cut and size the dressing and the ability to affix the StingRay anywhere it needs to fit comfortably, more than outweighs the added effort.  Secondly, and as discuss at length above, the Enluxtra’s clinically proven advantages over a simple absorbent dressing make the extra effort more than worth it.

Any component of the MicroDoc System can be ordered separately.  You can find any component on the Accessories page.

You could, but why would you want to?  Anyone can make a vacuum pump, the MicroDoc difference is in the Enluxtra dressing.  That is the part of the system that comes in direct contact with your wound.  Why would you want to minimize the healing attributes of the Enluxtra dressing by switching to what other systems use.  The risk of maceration is too great when you are not using our self-adapting Enluxtra dressing.

The software in the MicroDoc absolutely minimizes the amount of battery drain when the system is not in use.  The batteries will last almost as long as if they were still on the shelf in your local battery store.
We have also equipped the MicroDoc with high energy batteries to make sure they last a very long time.

The three pressure settings were chosen for very forthright and logical reasons.

• 50mmHg—After thorough testing in actual clinical situations, many believed that 50mmHg was the most preferred pressure level for use with the Enluxtra dressing.  This pressure setting was aggressive enough to pull down the dressing and maximize the skin contact surface area of the dressing with the wound.  Yet it maximized the useful life of the dressing by not pulling the absorbed exudate more quickly than it should to the edges of the dressing necessitating a dressing change.
• 80mmHg—This setting was chosen because many of the other systems have a setting at or near this pressure level.  We did not want to be ruled out as a viable competitive product because we didn’t at least offer a setting at this level.
• 125mmHg—As almost all will attest who regularly use negative pressure wound therapy, this pressure level is the most widely accepted pressure setting in the healthcare arena.  As above, we wanted to make sure we overcame any objections up front regarding the use of the MicroDoc, as many wound professionals prescribe 125mmHg as their default setting.

It is vitally important to note, that the MicroDoc can be safely used at any of the three pressure settings.   The prescribing wound professional will make the decision as to which setting works best for them and their wound healing goals.

At first look it would seem like the small MicroDoc could not possibly offer the same levels of therapies as the big, traditional sized units.  But it is not trying to achieve that goal.  The MicroDoc does not have the capability to treat very large and cavernous wounds that might fill a 300cc or even 800cc canister in less than a week.
But when a wound’s healing has progressed to a point where it is shallower and exuding less, a thick foam dressing can be contraindicated on these wounds and in fact can cause damage to the wound.  A foam dressing on top of a wound, or in a very slight depression, can cause serious maceration issues which can lead to having to start all over again as the wound can worsen.
For shallow wounds, with lower amounts of exudate and surgical scars, using the MicroDoc can be the best modality for these wounds.  And it can help reduce scarring after the wound has healed.  We have done numerous clinical trials after surgical procedures with amazing results.
And on the economic side of the equation, disposable single patient use systems are the fastest growing segment of the negative pressure wound therapy market.  When last we checked Smith & Nephew did more than $100 Million in sales of the PICO alone!

We would be the first to agree that the MicroDoc couldn’t hurt a fly and because of the Enluxtra dressing, your patient is receiving good care even if the MicroDoc is applied incorrectly and not functioning at top efficiency.   But until something changes, negative pressure wound therapy requires a prescription, no matter how small or large the system being used.

All I can say is that great minds think alike.  We already have plans to make that change (and product improvement) based upon the success of this product category.  Our manufacturing partner is willing to make that change as soon as it financially viable for him to make that change.  Simply put, they will spend the time, energy and effort to make the change based upon our usage and order levels.

A great question and one in which we wholeheartedly agree.  And we are working on that; but first a little backstory.
To get our FDA 510(k) approval, the rules of the game are such that the best and most efficient way to get 510(k) approval is to show equivalency with a predicate (already 510(k) approved) product.  So we created a product that matched the useful life of the Smith and Nephew PICO, but added in a few Pensar improvements that clearly makes our product a better product.  Why they felt 7 days was the magic number, we will never know for sure.  But it can be something as simple as that is how long their micropump lasts before dying.  In numerous competitive tests, we believe this may have played a major factor in their 7 day life as many of the PICO’s in testing failed to even last that long.
But secondly and more importantly, in the coming months we hope to introduce another product, the MicroDoc Alaira, that is equipped with a longer lasting pump AND replaceable batteries.  This product will still be classified as a single patient use disposable item, but the beefier motor and the ability to replace batteries will allow the user to help heal that wound for as long as it takes.
We are hopeful that when the time comes the FDA will see the logic behind our next product making approval easier than trying to create a new product concept at this time.