Daily Health and Medicine News

Technique Stimulates Growth of New Blood Vessels of Heart Disease Patients

New method could be used to treat heart disease

University of Pittsburgh researchers have developed a new method for regrowing blood vessels with growth factor, which could be used to treat heart disease.

Yadong Wang, study leader and University of Pittsburgh professor, along with co-authors Johnny Huard, Hunghao Chu and Chien-Wen Chen, have found a minimally invasive technique for transferring growth factor into mice via injection, which stimulates the growth of new blood vessels.

The human body has growth factors that control activities like cell proliferation, differentiation and migration. These potent molecules can even cause cell suicide and promote cell growth. The problem is that the body strictly controls growth factor, and the body will destroy “free-floating” growth factor.

But now, Wang and his team have created a method that overcame this problem. Despite the half-life for most growth factor (injected under the skin) being a half hour or less, researchers decided to inject the growth factor under the skin of mice directly onto a molecule called heparin, which bonds growth factor to its receptor on the cell’s surface. As the receptor and the growth factor bind to heparin, the activity of growth factor is increased and stabilized.

This may have solved the problem associated with growth factor duration, but it also caused another road block: bonding heparin to growth factor results in a water-soluble substance, which is a problem because a majority of the human body is made up of water.

But this issue didn’t stop the University of Pittsburgh team for long. They found a positively charged molecule, called polycation, which possesses many positive charges to counter heparin’s many negative charges. This neutralized the heparin and brought it out of solution into a coacervate, which is an aggregate of small oil droplets.

The team was able to successfully deliver fibroblast growth factor-2 as a result of the conversion of heparin/growth factor complexes into coacervates. Using only one growth factor, the researchers injected the compound under the skin of mice, which caused new blood vessels to grow. In addition, the blood vessels were still in place over a month later.

“We had structures that resembled arterioles — small arteries that lead to a network of capillaries,” said Wang.

The procedure is minimally invasive because the coacervate is not very viscous, meaning that you can use a thin needle to inject the growth factor through tissue and the damage created in small. It could also be used through a catheter, meaning that the chest wouldn’t need to be opened up for open-heart surgery.

The idea behind this discovery is to use growth factor to help the heart heal itself after a heart attack without negative results, like dilating ventricles until they become too large. The growth factor would be injected right after the heart attack to help the heart repair itself.

“Our hope would be to reduce scarring, keep as much of the muscle alive as possible, and induce quick blood vessel formation to bring as many nutrients as possible in order to reestablish an environment for muscle growth,” said Wang.

The team will use a disease model next to test this method before moving on to human clinical trials. If all goes well, the final step will be to commercialize the treatment.

Study: Heart procedures driven by profit, not science

Heart disease kills more Americans than anything else. While the statistics cause great concern, some providers see this is as an opportunity to cash in by marketing expensive, unnecessary heart procedures to healthy patients.

A recent investigation by Consumer Reports Health indicates that the practice of healing hearts has become a money-making machine that too often favors profits over science.

“We’re concerned that some people are having too many tests and too many treatments as a result, and some of that’s driven by profits, not good science,” reiterated Dr. John Santa, director of the Consumer Reports Health Ratings Center.

Most patients would say that my heart is very important and there’s no amount of money that would preclude me from getting some type of test to make sure that my heart is healthy, “Early Show” co-anchor Chris Wragge points out.

While Dr. Santa recognizes this concern, he says, “There are good and inexpensive tests and many of those aren’t being used as often. It’s frustrating because many tests that are expensive potentially dangerous and aren’t effective are being used.”

What are some of the tests that indicate people are overdoing it?

“We did a survey of almost 1,200 healthy (people) 40 to 60 years old, no disease, no symptoms and no risk factors and found 44 percent were getting ineffective tests, like EKGs, stress tests or ultrasound of the carotid arteries,” he adds.

According to Santa, there are negative effects, aside from the costs. “These tests aren’t precise when it comes to detecting early disease so they can be false positives, you get a cascade of additional tests and sometimes treatment including angioplasty, you could end up with a metal stent in your coronary artery for the rest of your life and may not need it,” he explains.

Are doctors giving bad advice?
“In some cases, unfortunately they are,” he said. “Most doctors are emphasizing the big five tests: blood pressure, cholesterol, diabetes, taking small doses of aspirin and stopping smoking. Those are the big five, but obviously doctors are, in some cases, recommending tests that aren’t very effective, and in some cases treatment that isn’t.”

What advice can Dr. Santa offer to patients who trust their doctor for the most part?

“They need to do research and use tools like we’re offering that offer ratings of these tests, also offering ratings of heart surgery groups, so that they can more easily sort out who are the best heart surgeons to have their surgery,” he said.

Exactly what goes into the whole ratings system?

“It’s a three-star system, 323 heart surgery groups across the country have released this data. Eighty-one of the groups are three-star, very good performance information, 238 are average and five below average,” he explained. “The important thing for patients to know, almost all heart surgeons have this information. Ask them for it. And if they aren’t willing to give it to you, maybe you should look for another surgeon. Do your research. Don’t just take the advice of your doctors.”

Sunshine Heart Appoints New US Board Member

Sunshine Heart, Inc. (asx:SHC), a global medical device company focused on innovative technologies for moderate heart failure, today announced the appointment of Gregory Waller as an independent non-executive director. Mr. Waller brings more than 30 years of financial management and industry experience to Sunshine Heart with an established history of serving on the boards of several successful medical device companies. He is the second US-based board member to be appointed this year following the appointment of Paul Buckman in January.

Mr. Waller was with the public company, Sybron Dental Specialties, for 25 years until he retired as Chief Financial Officer in 2005. During his career with Sybron, Mr. Waller contributed to the company’s growth from $10 million to $750 million in sales. Serving in a variety of operational and financial management positions, he was instrumental in closing multiple rounds of financing for the company. In addition, he oversaw Sybron’s initial public offering and its acquisition of more than 30 companies worldwide until its eventual sale to Danaher Corporation in 2006 for $2.6 billion (representing a $2.1 billion gain to shareholders).

“Few industry veterans have taken a company to the success that Gregory Waller has and we are honored to welcome him onto our board,” said Nick Callinan, Sunshine Heart’s Chairman. “Mr. Waller has an outstanding track record on the boards of fast growing medical technology businesses, many of which have now become established public companies. His vast experience with the cardiovascular market will also be extremely valuable to us.”

Mr. Waller currently serves on the board of Endologix Inc., which develops and manufactures minimally invasive treatments for vascular disease. He helped develop the strategic direction for Endologix, assisted in the development of the audit committee procedures and processes and helped raise substantial capital, taking Endologix’s market cap from $175M to $470M.

In addition, he has previously held board positions with Alsius, Inc., Cardiogenesis Inc., Clarient, Inc., and SenoRx, Inc., where he played an instrumental role in each company’s acquisition or IPO.

“It is a privilege to join the board of Sunshine Heart as I believe the Company has an exciting future ahead of it,” said Mr. Waller. “The unique C-Pulse system has the potential to become a leading treatment for Class III heart failure, representing a tremendous opportunity in the cardiovascular heart failure market. I am particularly looking forward to working with Dave Rosa, CEO of Sunshine Heart, to help navigate the continued financial success of the Company.”

Mr. Waller has been a featured speaker for the Center of Corporate Governance as well as a panelist at the Forum for Corporate Directors meetings.

“The diversified expertise that Mr. Waller brings in financial management, corporate governance, auditing and fundraising will support Sunshine Heart’s growth and the continued achievement of our corporate goals,” Mr. Callinan added. “These include securing additional capital to complete a U.S. FDA pivotal trial for our C-Pulse Heart Assist system, to support regulatory approvals outside the U.S., as well as to fund continued enhancements to the C-Pulse system.”

This press release does not and shall not constitute an offer to sell or the solicitation of any offer to buy any of the securities. The shares of Sunshine Heart have not been registered under the Securities Act of 1993 (US Securities Act) and may not be offered, sold or delivered in the United States, or to, or for the account or benefit of, any US Person, as such term is defined in Regulation S of the US Securities Act. In addition, hedging transactions with regard to the shares may not be conducted unless in accordance with the US Securities Act.

About the C-Pulse(R) Heart Assist System The C-Pulse Heart Assist System utilizes the proven scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Operating outside the patient’s bloodstream, the novel extra-aortic approach of the C-Pulse technology offers greater flexibility allowing patients to disconnect as necessary or desired. The C-Pulse system’s potential benefits may help reverse the heart failure process or maintain the patient’s current condition, thereby preventing the need for later stage heart failure therapies, such as left ventricular assist devices (LVADs), artificial hearts or transplants.

About Sunshine Heart(R) Sunshine Heart is a global medical device company committed to the commercialization of the C-Pulse Heart Assist System, a minimally invasive, implantable, non-blood contacting, heart assist therapy for the treatment of moderate heart failure. C-Pulse relieves the symptoms of heart failure through the use of counter-pulsation technology which enables an increase in cardiac output, an increase in coronary blood flow and a reduction in the heart’s pumping load. The Company has completed enrolment of an approved US Food and Drug Administration (FDA) 20patient U.S. clinical trial with the C-Pulse System. Sunshine Heart is a Delaware-based Corporation headquartered in Minneapolis with a subsidiary presence in Australia. The Company has been listed on the ASX since September 2004.
Forward-Looking Statements

This announcement contains forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation, our expectations with respect to the progress of, and presentation of data related to, product development and commercialization efforts, results of clinical trials, expected timing of FDA regulatory filings, FDA acceptance of our filings and research and development activities, ultimate clinical outcomes and benefit of the Company’s products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. Sunshine Heart does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Sunshine Heart may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation, the possibility the FDA does not accept our regulatory application or approve the marketing of the C-Pulse(R) Heart Assist System in the U.S., the possibility the Company may be unable to raise the funds necessary for the development and commercialization of its products, the possibility the Company may be unable to successfully list its securities on a U.S. securities exchange, and those described in our filings with the ASX. We may update our risk factors from time to time in our filings with the ASX.