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Renal Denervation Technology from St. Jude Medical Demonstrates Significant ... - MarketWatch (press release)

ST. PAUL, Minn. & PARIS, May 16, 2012 (BUSINESS WIRE) -- --Trial showed double the reduction in blood pressure of competitive technology in the same timeframe

St. Jude Medical, Inc. /quotes/zigman/242119/quotes/nls/stj STJ -0.57% , a global medical device company, today announced that preliminary data demonstrated the company's EnligHTN(TM) renal denervation system was safe and effective for the treatment of resistant hypertension. The study demonstrated that on average patients with resistant hypertension experience a systolic blood pressure reduction of 28 points after 30 days.

Renal denervation is a specialized ablation procedure that has been clinically proven to reduce blood pressure in patients with hypertension that is resistant to medical therapy. A typical normal blood pressure is below 120 systolic (the first number) and 80 diastolic (the second number), and is expressed as 120/80 mmHg. Hypertension, or high blood pressure, is a blood pressure greater than 140/90 mmHg.

Patients that enrolled in the trial had an average of 176 / 96 mmHg baseline blood pressure despite being on multiple medications to help control blood pressure. The results after 30 days demonstrated:

-- An average blood pressure of 148 / 87 mmHg, a 28 point reduction in systolic pressure

-- A reduction in systolic blood pressure to below 140 mmHg in 41 percent of patients

"The risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure, so an average blood pressure reduction of 28 points is quite significant and demonstrates just how effective the technology is," said the trial's Primary Investigator Prof. Stephen Worthley, Royal Adelaide Hospital in Australia. "From other clinical trials studying the impact of renal denervation we have learned that blood pressure continues to be reduced over time, so I would not be surprised to see this trend continue and see an even greater benefit for patients."

Results from other clinical trials for competitive technologies studying the safety and efficacy of renal denervation demonstrated that results improve over time. After 30 days, a 14 point reduction in systolic blood pressure was noted in a competitor's study, but this number improved to a reduction of 27 points of systolic blood pressure after one year. Compared to this competitive technology, the average 30-day results from the EnligHTN renal denervation trial showed double the reduction in blood pressure at 30 days. Further, the renal denervation treatment was successfully delivered with no serious complications related to the procedure or device.

Forty seven patients enrolled in the multicenter study. To be considered for enrollment, patients were required to have a systolic blood pressure above 160 (150 for patients with type 2 diabetes) and take at least three antihypertensive medications concurrently at maximally tolerated doses, including a diuretic.

"Hypertension accounts for millions of deaths every year, so it is encouraging that just ahead of World Hypertension Day, new data demonstrate that there is a safe and effective solution to help reduce blood pressure in patients where other treatments aren't working," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. "The EnligHTN system is truly a unique technology that we believe has the potential to reduce a root cause of some of the world's most burdensome cardiovascular diseases and help patients around the world live more healthy lives."

Hypertension is a root cause of various life-threatening health problems, including heart disease, stroke, and kidney failure. It impacts more than 1 billion people globally, many of whom do not respond to conventional treatment with medication.

About the EnligHTN Renal Denervation System

The EnligHTN system is a multi-electrode ablation technology for renal denervation. With its unique basket design, each placement of the ablation catheter administers a reliable and repeatable treatment pattern. Compared to single-electrode ablations systems, the multi-electrode EnligHTN system has the potential to improve consistency, save time as well as result in workflow and cost efficiencies. Additionally, minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (x-ray) exposure.

Using the new EnligHTN system, an ablation catheter delivers radiofrequency (RF) energy to create lesions (tiny scars) along the renal sympathetic nerves -- a network of nerves that help control blood pressure; the intentional disruption of the nerve supply has been clinically found to cause systolic blood pressure to decrease.

The technology includes a guiding catheter, ablation catheter and ablation generator. The generator uses a proprietary, temperature-controlled algorithm to produce effective lesions.

St. Jude Medical recently received CE Mark approval for the EnligHTN renal denervation system. Attendees of EuroPCR can see the EnligHTN system on display at the St. Jude Medical booth or visit www.SJMenligHTN.com .

EuroPCR is the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), a leading international course for interventional cardiovascular specialists.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2012. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

SOURCE: St. Jude Medical, Inc.




        
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Life Connected: Kidney Recipient Becomes Donor - NBC Los Angeles
Photos and Videos <![CDATA[ div.vidc { width:576px; height:324px; } ]]>

Life Connected: Driving Away Cancer

John Nikas is driving a 1953 Austin Healy across the country in an attempt to "Drive Away Cancer." The vintage car named Grace sports thousands of signatures that mark the memory of people who have battled cancer. Colleen Williams reports for the NBC4 News at 11 p.m. on May 8, 2012. <![CDATA[ div.vidc { width:576px; height:324px; } ]]> Life Connected: A Foster Home for Hundreds Patricia Negus and her husband Jerry have at, at their estimation, about 400 foster kids, who say they taught them how to love unconditionally and, in some cases, saved their lives. Gordon Tokumatsu reports for the NBC4 News of 11 p.m. on May 1, 2012. More Photos and Videos

Smiles, joy and laughter aren’t the norm in dialysis centers across America. Grueling hours of kidney treatment can wear down the soul, not to mention the body. But today, at DaVita Dialysis Center in Century City, young kidney patients wear smiles that light up the room. Smiles that, at least momentarily, eclipse the medical issues that have brought them together.

Today, the source of those smiles is Chad Eaton, a handsome 18-year-old whose life is forever connected with the young patients he’s visiting. Their lives are connected because for 18 years, he’s known their struggles, their pains, their fears. He knows, because he too has battled kidney disease.

Chad was born with two defective kidneys. Doctors removed one when he was just 18 months old, telling parents he’d also need a transplant eventually. Surviving with one poorly functioning kidney was often difficult for Chad, sapping him of the energy that came so natural for his peers. But it wasn’t just difficult for Chad. His parents, Jim and Julie Eaton, dealt with the hardships of the disease: the doctor visits, the medications, the stress. It took a toll on all of them. “It’s a strain on everyone in the family,” Chad’s father Jim said as he fought back tears. “You have an underlying pressure and stress and you don’t always realize it’s there. But in the back of our mind we always knew it was going to be okay, that he was going to be okay.”

Yet their son was more than okay on the baseball diamond. A promising pitcher at Campbell Hall High School in North Hollywood, Chad routinely stared down, and mowed down, opposing hitters. But after his junior season, Chad’s energy began to wane severely. Doctors told Chad he needed to go on dialysis. So for ten hours, every night, Chad hooked himself up to a dialysis machine, hoping the treatment would help his rapidly weakening kidney. “I definitely was frustrated,” Chad reminisced. “Especially during baseball. Junior year I got really tired, everything came falling down.” His mom Julie, could hardly handle what her son was going through. “It was the worst. I have never yelled at doctors until they put my son on dialysis. I lost it. I never cried in front of him. I would wait, say ‘good night, I love you,’ but I would cry and cry every night.” Tears were common for Chad too. “Your whole life falling down on your gets so depressing at times. I got so sad at points, I just couldn’t deal with things but I realized that one day I’m going to get a transplant and everything’s going to be better.”

Four games into his senior year, Chad’s season came to an abrupt end. Doctors told him the time had come for a transplant. So on March 10, Chad took one last walk to the mound, pitching the final game of his prep career. He poured his heart and soul into that game, turning in one of his best games of his life. He struck out six and came one batter short of pitching a complete game.

Chad walked off the field to a standing ovation.

Two days later he was at Ronald Reagan UCLA Medical Center, awaiting a kidney he’d been promised as a young boy. His aunt, Susan Launer, said she made a vow to Chad when he was just a baby because she loved her nephew and wanted to her sister smile again. “I said ‘hey kiddo,” I’ll give you one of my kidneys. I didn’t really think I was going to and then fast forward 15 years later, yeah, there it is.”

With his 18th birthday just days away, Chad was wheeled into an operating room. After several hours of transplant surgery, Chad’s doctors proclaimed the operation a success. Just days later, Chad took the first steps of his new life and he had his aunt to thank. “She is the person who has given me a new life,” Chad said. “She is the person who is making me stronger, making me healthier, making me a better person.”

Throughout his trials and countless hours of treatment, Chad often wondered when things would get better. It was during those moments that Chad decided he could make things better. Not for himself, but for others going through the same trying experiences. So Chad started his own nonprofit, Recycle For A Charity, soliciting electronics, toys and donations for young kidney patients. “I just want to give hope to other kids out there going through the same situation. I know they’re down sometimes and I want them to know things can be better.” The day before his transplant surgery, while he should have been fretting about going under the knife, Chad worked diligently on his charity’s Web site, looking forward to the day he’d bring smiles to the faces of kidney patients just like him.

A mere seven weeks after transplant surgery, Chad and his mother piled toys and gifts into the family car. Then they made a familiar drive to the exact dialysis center where he began his own kidney therapy. Chad said he wanted to give the kids hope, to make them happy. He said that’s all he ever wanted when he was on dialysis. He knew how to help because he’s been in their shoes and now, on a path to a better life, he wanted to make their lives a little better too. The moment he walked into the treatment room, patients and parents wore smiles so rarely seen in such conditions. Chad spent time with each of the patients, passing out pillows, video games, headphones and baseballs. “My favorite part of the day was making jokes with the kids. Them cracking jokes makes me happy because I know they’re happy.

It was easy to know just how joyful everyone in the room was that day. Jennifer Banh, Child Life Specialist at DaVita Dialysis, remembered her former patient and was thrilled to see him return. “To see Chad come back to our unit, it makes me happy to know he looks good and is going to have a long and healthy life.” His visit made a strong impression on the patients as well. “I actually look up to him,” 17-year-old Giovanni Encalada, Jr., admitted. “When I first started on dialysis it was pretty hard on me. When I see him come tell me it’s all right, I finally realize it’s something that can pass over.”

As much as the patients’ spirits were lifted, the person in the room with the biggest smile was Chad’s mom Julie. “I haven’t seen him smile since before his transplant. Seeing him smile with all these kids, he’s a new kid. He has a kidney and I think he made a bunch of new friends today.” Hugs and handshakes made that reality clear. Thiers are lives connected on a level few others could ever know, a connection others could never imagine. “That’s why I started the charity,” Chad said. “I know what they’ve been through and when I see them happy it makes me happy. I just want to give them hope that things are going to be better.”


To learn more or to donate to Chad’s nonprofit, visit www.recycleforacharity.com.

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Province delaying dialysis service move - The Guardian Charlottetown

The provincial government is delaying its decision to consolidate dialysis services so it can have more discussions with people in the affected communities.

On Tuesday, Premier Robert Ghiz said the government hadn't planned to make the change for at least six months but will wait another six months to a year.

"But again it's about dialog," he said.

Last month, Health Minister Doug Currie announced the province planned to move dialysis services out of Alberton and Souris.

The plan was to reduce the number of sites from four to two and consolidate the service in Charlottetown and Summerside, but after meeting with Alberton residents Monday the government decided to delay that move.

Even with the delay, Ghiz said Health Minister Doug Currie got the decision right when it came to moving the dialysis service.

"It's important to have dialogue on certain issues where there's an opportunity to do that and that's exactly what we're going to do," he said.

When asked if there is a possibility the government could reverse its decision to move the dialysis service out of Alberton and Souris, Ghiz said he thinks there are always going to be changes in health care.

The delay will give the government time to make sure its resources in the best way possible while taking everyone's concerns into consideration, he said.

"That's really what we're trying to do."

Alberton-Roseville MLA Pat Murphy said he was happy with the decision to delay the move.

"It will give us a chance to have a good second look at it," he said.

Murphy said in the recent meeting with government the residents made some good points and Ghiz listened to their concerns.

"I'm pleased that he decided to take the time to have a second, closer look at the whole decision," he said.

For Souris-Elmira MLA Colin LaVie, he said the decision to delay the change is just prolonging the agony for people in his riding, which isn't what they want.

"We want their dialysis," he said.

LaVie said there wasn't a dialogue between the government and residents before the decision was made.

"Why don't they go to the people and then their decisions will be a lot easier," he said.

He called it a flip-flop on the issue and said the decision to delay the consolidation was the opposite of what people who need the service wanted.

"It's more of a flop than a flip."

Currie said the delay doesn't change increasing demand for dialysis treatment or the complexities of the patients who need the service.

"Obviously the communities spoke and as a minister that was important to me and we have to pay attention to those concerns," he said.

The decision is delayed, but that won't slow down the growth in demand for dialysis service, he said.

"We have some issues when it comes to chronic disease and as a result of chronic disease we have issues facing the ability to provide quality dialysis services."

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Dry weather prompts fire ban - Fort McMurray Today

Current forest fires appear to be caused by humans: SRD

By Jordan Thompson

Posted -42 second ago

A fire ban is now in place for all forested areas of Alberta, Environment and Sustainable Resource Development announced Monday.

“The wildfire situation in most of Alberta is serious,” said ESRD minister Diana McQueen in a release. “Unfortunately, most of the wildfires we are fighting right now appear to be human-caused and therefore were 100% preventable. It is very important that everyone take precautions to avoid starting fires — it is so dry and windy in many places that fires can start and spread very quickly.”

With the Waterways wildfire hazard level still sitting at “high,” the fire ban covers all of Waterton Lakes National Park, extending to include areas north and east of Manning, Alta., north of Fort McMurray and everything south of Township 93. The fire ban prohibits the lighting of outdoor fires, fireworks, and the use of portable campfires. As well, all fire permits issued under the Forest and Prairie Protection Act are now suspended in the ban area.

As wildfires continue to burn in the Grassland, Bonnyville and Lodgepole areas, ESRD is constantly trying to raise as much awareness as possible on the topic of fire safety. Since the beginning of April, ESRD has responded to more than 270 wildfires, most of which appear to be human-caused.

Residents are reminded to check off-highway vehicles for burnable debris on hot spots of the vehicle, such as the engine or exhaust. All OHVs in Alberta are required to have a functional muffler and spark arrestor.

When the fire ban is eventually lifted, and citizens can begin enjoying campfires again, they are reminded to either use a designated fire pit, or select a site away from dry grass, heavy bush, leaves, logs and overhanging branches. Campfires should always be kept small, never left unattended, and always properly extinguished. Any campfire left unattended is technically considered a wildfire.

People who violate a fire ban can be charged under the Forest and Prairie Protection Act and could face a fine of up to $5,000. As well, the responsible party can be held accountable for the costs associated with fighting a resulting fire, with no maximum limit.

And if protecting Alberta’s forests and wildlife isn’t enough of a reason to practice fire safety, a recent study by The Lung Association reports that wildfires are also damaging lung health. Wildfire smoke is made up of small particles, vapours, and gases, including carbon monoxide, nitrogen oxide and air toxins, which can make breathing difficult.

“Forest fires are certainly a concern for those with breathing difficulties or chronic lung diseases,” said Beth Nanni of The Lung Association. “The air will have more smoke particles than usual and they could find it difficult to breathe outdoors. Proximity to the fires and prevailing weather conditions will dictate whether the smoke lingers in an area and how much the local air quality is affected.”

Residents concerned about their lung health in the midst of multiple wildfires burning in the area can check out environment.alberta.ca/apps/aqhi/ to see whether smoke is an issue in their region.

“The Air Quality Health Index will always have the most up to date information on air quality,” Nanni said. “Individuals should be aware if smoke in the air is a trigger for them and speak with their doctor or respiratory health professional.”

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Young organ donor advocate gets new kidney, so he “can be a real boy” - HealthCanal.com

Ann Arbor, Mich. –When he was little, Jai’Wan Davis-Harbour loved the story of Pinocchio. He believed he had a lot in common with the storybook character. Jai’Wan felt he wasn’t a real boy, because his kidneys didn’t work.

But on May 9, after about a 4-year wait, years of dialysis treatments and 65 surgeries, Jai’Wan received a successful kidney transplant at C.S. Mott Children’s Hospital. Because of a generous organ donor, Jai’Wan, 11, got a second chance at life.

“This is his home run,” said his mom, Cherisse Davis-Harbour, as her son was wheeled to the operating room.

Jai’Wan was born with renal dysplasia, and his kidneys did not form normally from birth. He received his first kidney transplant in 2004 when he was just 3 years old. But his body rejected that organ and it had to be removed.

That transplant caused Jai’Wan to be sensitized to foreign tissue, like a donor organ, making it difficult to find a match. Jai’Wan has been participating in the University of Michigan Transplant Center’s Kidney Desensitization Program. Desensitization can remove the antibodies built up using medications and a process similar to dialysis, improving the chances that a donated kidney will not be rejected by the recipient’s body.

That desensitization helped Jai’Wan, and this kidney is also a very good match, says his surgeon, John C. Magee, M.D., professor of surgery at the University of Michigan.

“Jai’Wan was very lucky that a donor organ was found. The surgery went well and the kidney began working right away. This is going to be a really good thing for him,” says Magee.

Jai’Wan worked with Michigan Secretary of State Ruth Johnson and Gift of Life Michigan to promote organ donor awareness and encourage state residents to sign the Michigan Organ Donor Registry.

His picture was featured on posters in Secretary of State branch offices in southeastern Michigan, he appeared at a press conference and did interviews and shared his story in a Gift of Life video.

“In his 11 years, Jai’Wan has gone through more medical procedures than most people will have in a lifetime,” Johnson said. “Today, because of the incredible gift of another family, he now has the chance to pick up a bat and play baseball like he always wanted to do.

“But sadly, too many Michigan people still are waiting for a life-saving transplant. Please take a moment to join the Michigan Organ Donor Registry, and encourage your friends and family members do the same.”

In Michigan, there are nearly 3,000 people on the waiting list for a life-saving organ transplant, says Richard Pietroski, chief executive officer of Gift of Life Michigan, the state's organ and tissue recovery organization.

"Because of the generosity of a donor and their family, there's now one less person on that list. We are so happy that Jai'Wan has received this gift, and we are so grateful to the donor and that individual's family for their willingness to think of others during a time of grief," Pietroski says.

Jai’Wan hopes to join a baseball team soon. But this July 17, he already is scheduled to throw out the first pitch at the Detroit Tigers game. For that game, the Donate Life Coalition of Michigan partners with the Detroit Tigers to raise awareness of organ donation and give fans a chance to sign the organ donor registry.

Jai’Wan’s already been practicing, and watching his favorite Tiger, Justin Verlander, on the mound. But now he’s happy that he’ll have a new kidney when he takes the field in July.

Jai’Wan named his first kidney Pinocchio, and his new one is Pinocchio 2.

“I want to say thank you to my donor,” Jai’Wan says. “I am so happy that I’m going to feel better.”


About the University of Michigan Transplant Center: U-M has one of the oldest and largest transplantation programs in the country and U-M surgeons perform transplants of hearts, lungs, pancreases, livers, kidneys, and corneas. About 400 to 450 transplants are done at U-M annually, mostly kidney transplants followed by liver, heart, lung and pancreas. Since the first transplant in Michigan took place at the University of Michigan back in 1964, more than 7,600 patients have benefited from our program.


Signing up on the Michigan Donor Registry is simple. Go to www.giftoflifemichigan.org, Gift of Life Michigan is the state’s federally-designated organ and tissue recovery organization and acts as intermediary between donors, their families and hospital staff. Gift of Life Michigan, in collaboration with the Michigan Eye-Bank, provides all services necessary for organ, tissue and eye donation.

 

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Media Contacts      Mary Masson: This e-mail address is being protected from spambots. You need JavaScript enabled to view it 734-764-2220

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