Who will be the next Medtronic? What will be Minnesota's next breakthrough industry? James Walsh will provide the latest information and commentary on the people, companies and trends driving innovation in Minnesota. From visionary entrepreneurs to game changing technologies, this blog offers a window into the future of Minnesota's economy.
Medtronic on Monday announced the enrollment of the first patient in its Victory AF clinical trial, a study involving patients with persistent or long-standing persistent atrial fibrillation. Patients in the trial will undergo a procedure with Medtronic’s Phased Radiofrequency (RF) system. The study will evaluate the safety of the system, while collecting data on the system’s effectiveness.
The system delivers customized radiofrequency energy to eliminate or block abnormal electrical impulses in the left atrium that initiate or sustain atrial fibrillation. The multi-electrode catheters are intended to allow doctors to identify and selectively ablate a broad area of heart tissue without the need for single-point catheters or complex mapping and navigation equipment.
The Medtronic Phased RF System is currently approved for use in areas of Europe, Asia, Africa, Australia, and Canada. More than 20,000 patients in 26 countries have been treated since January 2009. The system is not yet approved for sale in the United States.
Up to 350 patients will enroll in the trial at 40 centers in the U.S., Canada and Europe. The trial will examine the 30-day procedure-related stroke rate and device-related stroke rate. Six-month effectiveness, as well as rates of pulmonary vein stenosis and acute procedural success, will also be measured.
The principal investigator is Dr. Greg Michaud, assistant professor, Harvard Medical School, and director of the Center for the Advanced Management of Atrial Fibrillation at Brigham and Women’s Hospital in Boston. The first patient in this study was recently treated by Dr. David DeLurgio of Emory University Hospital Midtown in Atlanta.
“In strong collaboration with the [U.S. Food and Drug Administration], we designed the VICTORY AF trial to evaluate the safety of Phased RF ablation in patients who suffer with persistent or long-standing persistent AF,” said Reggie Groves, vice president and general manager of the AF Solutions division at Medtronic. “We expect this trial will demonstrate its safety and benefit for this patient population.”
Persistent atrial fibrillation is defined as lasting more than seven days but less than one year, or lasting fewer than seven days but requiring treatment with medication or electrical current. Long-standing persistent AF is defined as lasting more than one year but fewer than four years.
In the United States, AF ablation catheters currently are available only for treating the mildest form of AF, in which the heart’s upper chambers beat rapidly and irregularly during episodes lasting from a few minutes to a few days. AF can progress into a persistent or long-standing persistent state, where patients often cannot be effectively treated with medication. Patients with persistent and long-standing persistent AF can have debilitating symptoms and are at elevated risk for stroke, hospitalizations and reduced quality of life.
Boston Scientific, a global medical technology company that employs thousands of Minnesotans, on Tuesday announced CE Mark approval of its X4 line of quadripolar CRT-D systems, including the AUTOGEN X4, DYNAGEN X4, and INOGEN X4 cardiac resynchronization therapy defibrillators (CRT-Ds) -- as well as its ACUITY X4 quadripolar LV leads and the ACUITY PRO lead delivery system. Leads are the wires that connect defibrillators and pacemakers to the heart.
The ACUITY X4 leads are designed with multiple electrodes that help doctors accommodate differences in patient anatomy. With multiple electrodes, the device can deliver therapy even if there is scar tissue that could block an electrical signal. The leads also feature multiple options for attaching the lead to the heart, as well as what Boston Scientific said is the industry's smallest lead tip to enable doctors to access blood vessels unavailable to other quadripolar leads.
One of the first implants was performed by Prof. Antonio Curnis, head of Electrophysiology, Brescia University, Civili Hospital, Brescia, Italy, and Dr. Luca Bontempi, an electrophysiologist.
"The unique design of the ACUITY X4 lead allows me to pace from more optimal locations while enabling excellent stability of the lead, low battery consumption and avoiding phrenic nerve stimulation, which are all important issues for CRT patients," said Prof. Curnis. "Thanks to the 17 pacing vector options, it is possible to manage micro dislodgments of the lead and optimize pacing threshold without additional procedures, drastically reducing the risk to patients. This, along with Boston Scientific'soutstanding battery technology, delivers a CRT-D system that truly benefits patients over the long term."
Following CE Mark approval of the X4 quadripolar CRT-D systems, Boston Scientific plans to start a global clinical trial to gather additional data. The device is not yet available for sale in the United States.
"Heart failure is a major cardiovascular problem and CRT-Ds can save lives and improve quality of life. The CE Mark approval of our innovative quadripolar CRT-D systems is truly a milestone when it comes to treating patients with heart failure and at risk of sudden cardiac arrest," said Michael Onuscheck, senior vice president and president, Boston Scientific Europe. "We are also excited to provide physicians with a CRT-D system that can significantly improve the implant experience."
For more information, go to: http://www.bostonscientific.com
St. Jude Medical on Thursday announced it has received European CE Mark approval for its 25 mm Portico Transcatheter Aortic Heart Valve Implantation System. The Little Canada-based company said the approval expands the number of patients who can be treated using the Portico heart valve during transcatheter aortic valve replacement (TAVR). TAVR is an option for patients with severe aortic stenosis (a narrowing of the aortic heart valve that obstructs blood flow from the heart) who are considered high-risk for open-heart valve replacement surgery.
“The addition of the 25 millimeter Portico valve broadens the patient population that can now be treated with this family of valves,” said Prof. Gerhard Schuler, head of the department of Internal Medicine/Cardiology at the University of Leipzig in Leipzig Germany.
“The fact that the Portico valve is repositionable prior to valve deployment helps ensure accurate placement, potentially improving patient outcomes,” said Prof. Axel Linke, an investigator in the Portico Transfemoral CE Mark Trial (Portico TF CE Trial), also from the University of Leipzig.
The Portico system is not yet approved for sale in the United States. European approval often comes two to three years before U.S. approval.
Made of bovine pericardial tissue attached to a self-expanding stent frame, the Portico valve is the first transcatheter aortic heart valve that can be brought back into the delivery catheter and repositioned or retrieved before being released from the delivery system.
“The Portico valve is an important part of our growing portfolio of products that treat valvular disease and heart failure. The approval of this 25 millimeter valve size will allow us to expand our footprint in the global TAVR market and provide a promising solution for patients with severe aortic stenosis,” said
During an implant procedure, the Portico valve is delivered through a catheter after a small incision is made to the femoral artery in the leg. Positioned while the patient’s heart continues to beat, use of the Portico valve alleviates the use cardiopulmonary bypass, which involves a machine taking over a patients’ heart and lung function during surgery.
Aortic stenosis is the most prevalent form of cardiovascular disease in the Western world after hypertension and coronary artery disease. Considered a potentially life-threatening condition, the aortic heart valve becomes calcified and does not open properly. Roughly 25 percent of people 65 and older, have aortic valve thickening and 3 percent age 75 and older have severe stenosis.
For additional information about the Portico valve visit SJMPortico.com
On Tuesday, St. Jude Medical announced a clinical study to look at burst stimulation as a potentially more effective –and tingle-free – way to manage chronic pain.
On Wednesday, the Little Canada-based medical technology company said it's launching another study regarding spinal cord stimulation – this one looking at whether combining SCS with peripheral nerve field stimulation (PNfs) offers more effective management of chronic low back and leg pain.
Peripheral nerve field stimulation and spinal cord stimulation involve implanting a stimulation device and small electrical wires, called leads. For spinal cord stimulation, the wires are places along the spine to block pain signals to the brain. For PNfS, wires are placed just under the skin in the subcutaneous tissue to stimulate the network of peripheral nerve fibers in order to reduce the pain at the location where it is most severe. PNfS is not the same as peripheral nerve stimulation (PNS), which targets a specific nerve. Instead, PNfS targets a more general network of nerves.
“We often see patients who have had multiple back surgeries to alleviate their debilitating chronic pain. Ultimately, many of these surgeries fail, leaving patients to seek other options like neurostimulation therapy,” said Dr. Porter McRoberts, an interventional pain physician at Holy Cross Orthopedic Institute in Fort Lauderdale, Fla., and the principal investigator in the study. “Peripheral nerve field stimulation therapy, targeting local nerves near the painful area, combined with traditional spinal cord stimulation, targeting the central nervous system, has the potential to improve our ability to effectively manage patients with difficult-to-treat low back pain.”
The SENSE trial is a randomized, prospective, multicenter, clinical study to demonstrate the safety and effectiveness of PNfS used in combination with spinal cord stimulation to manage low back pain and leg pain. The study will also look at whether the treatment is cost-effective. Up to 450 patients will be enrolled at up to 35 sites in the United States.
To qualify for the study, participants must have chronic low back and leg pain as a result of Failed Back Surgery Syndrome, a condition that refers to patients with back pain or leg pain despite lumbar surgery.
“Traditional spinal cord stimulation therapy has been used to manage chronic pain for more than 40 years and it works very well for many pain conditions,” said Dr. Mark D. Carlson, chief medical officer and vice president of global clinical affairs for St. Jude Medical. “Peripheral nerve field stimulation as an adjunct therapy has the potential to improve outcomes for those who struggle with severe chronic low back and leg pain.”
Neurostimulation, the use of electric stimulation to control chronic pain, continues to gain steam in the U.S. and abroad. On Tuesday, St. Jude Medical announced that it has started a clinical study of its Prodigy neurostimulator, a spinal cord stimulation system that delivers something called burst stimulation. It is the first of its kind, St. Jude said.
The SUNBURST (Success Using Neuromodulation with BURST) study will evaluate whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation that sends a continuous stream of electricity.
Spinal cord stimulation to manage pain has been around for more than 40 years. Implantable systems came into being as batteries became smaller and longer-lasting. The procedure involves implanting thin wires along the spinal cord. The wires are connected to a small pulse generator, similar to a pacemaker, that is usually implanted just beneath the skin. The generator delivers low levels of electrical energy to interrupt or mask the transmission of pain signals to the brain.
Patients with a traditional spinal cord stimulator feel the mild pulses of energy as a tingling sensation called paresthesia. St. Jude says that early research indicates that burst stimulation may be able to deliver therapy with little or no tingling and that it may be more effective than traditional stimulation treatment. It may even be more effective in managing complex back pain.
“Severe chronic pain has a debilitating effect on patients’ lives,” said Dr. Timothy Deer, an interventional pain physician, and president and chief executive officer of the Center for Pain Relief in Charleston, WV. “Burst stimulation may provide us with a comprehensive approach to managing patients whose pain is not adequately controlled with tonic spinal cord stimulation alone, or for those who lose therapeutic benefit over time. Importantly, we hope to demonstrate that burst stimulation produces paresthesia-free pain relief which may make it ideal for those who can’t tolerate traditional stimulation.”
The SUNBURST study will examine the safety and effectiveness of the Prodigy neurostimulation system that uses both traditional stimulation and burst stimulation therapy to manage patients with chronic intractable pain. A maximum of 442 patients will be enrolled at up to 50 sites in the U.S.
The Prodigy neurostimulator is not yet approved for use in the U.S.