The treatment of diseased heart valves continues to get more-and-more exciting as new technologies continue to shape the way that valvular disorders are corrected. In the minimally invasive space, Edwards Lifesciences, the largest heart valve replacement manufacturer on the planet, just received a CE Mark for its SAPIEN pulmonic transcatheter heart valve device (shown below).

As you may know, this device was designed as an alternative to surgical valve replacement for patients suffering from congenital heart disease of the pulmonary valve.

This device utilizes Edwards Lifesciences’ transcatheter valve technology — which has already been used in more than 5,000 cases worldwide. Interesting details of the Edwards SAPIEN pulmonic transcatheter heart valve include:

• The valve is a tri-leaflet design;
• The material used is bovine pericardial tissue (from a cow);
• The valve frame is constructed of stainless steel; and
• Prior to delivery, the tissue valve is compressed onto a balloon to the diameter of a pencil. It is then threaded into position, using a delivery system.

Sapien Heart Valve Replacement Device

In the United States, the Sapien Pulmonary Valve Replacement is an investigation device. It is currently being evaluated in the COMPASSION (COngenital Multicenter trial of Pulmonic vAlve regurgitation Studying the SAPIEN InterventIONal THV) clinical trial.

Also… Edwards recently announced clinical findings for Sapien’s use in aortic valve replacement procedures across 32 medical centers in Europe where the device is commercially available:

• Patients treated with the artery approach had a 81.1% one-year survival rate
• Patients treated with the between-the-ribs approach had a lower 72.1% one-year survival rate.

Yes, this data suggests that several patients died within a year of treatment. However, it is critical to remember that these patients were “high-risk” and often too sick to withstand the rigors of regular chest-opening surgery.

“The encouraging outcomes add to the evolving body of clinical evidence that demonstrates transcatheter aortic valve implantation is a viable option for this high-risk patient population. The data provide valuable, real world insights that enable the continued advancement of this important treatment for patients in need of alternative therapies to traditional open-heart surgery,” said Dr. Thomas, director of cardiothoracic services, Guys and St. Thomas’ NHS Foundation Trust in London.

Mike Mussallem – Edwards’ Chief Executive Officer

On the outlook for transcatheter devices, Mike Mussallem, the chief executive officer of Edwards Lifesciences, noted in a recent interview, “[Sapien] has not only big growth potential, but potentially changes the landscape for a very long time.”

Specific to that landscape, it definitely feels as if we are on the cusp of some form of transcather transformation specific to heart valve treatment. While there remains no long-term data on the durability of these devices, it is appropriate to acknowledge that these technologies from Edwards, Abbott Laboratories and Medtronic may initially help a select portion of the patient population suffering from heart valve disease (e.g. aortic stenosis, mitral regurgitation).

That said, I recently had the unique and fortunate opportunity to (i) interview a transcathether valve repair patient and (ii) observe a transcatheter procedure.  In the next few days, I will be sharing those experiences with you.

Keep on tickin!

Medical advances specific to transcatheter heart valve repair and heart valve replacement are exciting. Considering the patient benefits of these non-invasive technologies, it is expected that these approaches to heart valve treatment could create new, billion dollar products.

That said, it is very safe to assume that transcatheter valvular treatment is already competitive. To develop a competitive advantage, industry stalwarts are taking the appropriate steps to defend their intellectual property. Often referred to as the “secret sauce” in business circles, intellectual property is typically protected through patents and other legal means.

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Sarah just sent me this fascinating story about a new super glue, called Kryptonite, used to accelerate sternum healing following open heart surgery. I thought you might appreciate this medical advance featured in Science Daily:

Dr. Paul Fedak – Heart Surgeon & Scientist

Canadian researchers have pioneered a new way to mend a patient’s breastbone after open-heart surgery, using a Superman-strength glue that cuts healing time and reduces pain.The technique uses a state-of-the-art adhesive called Kryptonite that rapidly bonds to bone and accelerates the recovery process, says Dr. Paul Fedak, a cardiac surgeon and scientist at the University of Calgary.

“We can now heal the breastbone in hours instead of weeks after open-heart surgery,” he said Thursday. “Patients can make a full recovery after surgery and get back to full physical activities in days instead of months.”

Fedak said he came up with the idea of using Kryptonite, a biologically compatible adhesive made by a U.S. company, after watching many patients struggle with the aftermath of the surgery, which requires the breastbone to be split vertically to allow access to the heart (also known as a median sternotomy).

“So I fix their heart and they’re usually fine from a heart point of view, but a lot of them have prolonged pain after the surgery in the region of their breastbone,” Dr. Fedak said.

“We haven’t really innovated anything since cardiac surgery became routine 50 years ago, in terms of the chest closure. We’re still closing the chest the same way we always did with stainless steel wires and waiting for the bone to heal over six to eight weeks and hoping that it fuses.”

Augmenting the wires with the adhesive produces a solid bond within 24 hours, reducing time in hospital and allowing patients to resume physical activity sooner – an important component of surgical recovery in general and for heart rehabilitation in particular.

Fedak has used Kryptonite to mend the breastbones of more than 20 patients who had open-heart surgery as part of a pilot study. He is set to head an international trial using the technique, which will involve 500 patients over the next year or two.

One patient in the initial trial has had both methods of knitting his breastbone back together – and he said the glue takes the prize without question.

After Richard Cuming, 62, had cardiac bypass surgery two years ago, the wires holding his sternum together pulled out of the bone, leaving the two halves to rub together whenever he moved. The condition, called sternal disruption, is one of the potential complications arising from open-heart surgery.

“I couldn’t accomplish simple tasks like squeezing toothpaste, turning the steering wheel in my car or pulling open a heavy door without discomfort and pain,” he said.

Coughing or sneezing after heart surgery was “brutal,” Cuming said from his Calgary home, describing his pain level as up to eight on a scale of 10.

But when he had another open-chest operation in July to re-mend his breastbone using Kryptonite, there was a huge difference in his recovery.

“First of all, my chest was solid. I mean it was rock-hard, no movement. I could tell immediately that there was a significant improvement,” Cuming said. “The pain never did get much above a three on a scale of one to 10, and I managed it for the first couple of days in hospital with ibuprofen instead of any narcotic.”

A Common Pain Scale

Fedak has begun teaching the technique to other cardiac surgeons, both in-and-outside Canada. Among them is Dr. George Christakis of Sunnybrook Health Sciences Centre in Toronto, who calls the use of the adhesive “a terrific idea.”

“It will be good for patients and also great for hospitals, too, because keeping a patient in hospital for a long period of time takes up an enormous amount of money and resources. This would be very, very cost-effective.”

I don’t know about you… But, Kryptonite sounds like it really could have helped me through my recovery.

Keep on tickin!

I just received a great question from Lauren about aortic valve replacement and robotic surgery.

Lauren writes, “Hi Adam – I’ve read about the use of the da Vinci robot for mitral valve repair. But, I’m curious to know if the robot is ever used for patients with other valve disorders. I have aortic stenosis, due to a bicuspid valve, and would like to have minimally invasive surgery. Any thoughts? Thanks, Lauren”

The da Vinci Surgical Robot

If Lauren would have sent me this question two weeks ago, my response would have been something like, “From what I know, the only clinical valvular use of the da Vinci Robot is for mitral repair.”

However, earlier this week, ATS Medical announced some very interesting news about robotic surgical approaches using a biological valve replacement, known as the ATS 3f Aortic Bioprosthesis.

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Edwards Lifesciences, the world’s largest heart valve replacement manufacturer, continued to impress industrial and financial analysts after it reported another great earnings report earlier this week.

The company, based in Irvine, California, saw its profits more than double thanks to rising sales of replacement heart valves – including its new valve, known as the Edwards SAPIEN Valve.

The company now expects sales of the SAPIEN devices, also known as transcatheter heart valve replacements, to more than double to $110 million this year. These devices are currently on sale in Europe, and reports suggest that Edwards could get FDA-approval in the United States during the next few years.

FYI, earlier this week, I spoke with one of the heart surgeons who is currently working on the SAPIEN clinical trial, known as the PARTNER trial. His excitement specific to this new technology was overwhelming.

The SAPIEN valve can be threaded into place with a catheter in the femoral artery or delivered through an incision between the ribs. The valves are seen as an option for patients who are too sick or frail to withstand traditional heart surgery.

Edwards competes against Medtronic in Europe but believes it has a long head start in the race to the United States market. (You might recall that Medtronic recently acquired CoreValve to address this growing segment the heart valve market.)

Ultimately, these less invasive technologies provide several patient benefits including reduced physical trauma, shorter hospital stays and accelerated recoveries.

Keep on tickin!