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Minimally Invasive Device Industry Newsround

Source: St Jude Medical.

Teleflex Acquires Microlaparoscopy Surgical Platform Technology

US manufacturer of devices for critical care and surgery Teleflex has announced the acquisition of Eon Surgical, a late stage development company that has advanced a minimally invasive microlaparoscopy surgical platform technology designed to enhance surgeons' ability to perform scarless surgery while producing better patient outcomes.

Teleflex says that Microlaparoscopy, unlike NOTES (Natural OrificeTranslumenal Endoscopic Surgery) or single incision surgery, provides surgeons a mechanism for performing minimally invasive procedures without significant changes in technique. The technology has the ability to be utilised for an entire procedure or as an adjunct to existing approaches that require additional access without adding to larger incisions and the associated risks.

Two Real-World European Studies of Abbott's Minimally Invasive MitraClip Device Demonstrate Positive Outcomes for Patients with Mitral Regurgitation

US device maker Abbott has announced the publication of positive outcomes from two European post-approval studies of the first-in-class catheter-based MitraClip therapy for the treatment of mitral regurgitation (MR). Results from Access-EU, a European prospective study that enrolled 567 patients at 14 sites, have been published in the Journal of the American College of Cardiology. In addition, findings of the investigator-sponsored German TRAnscatheter Mitral Valve Interventions (TRAMI) registry, which enrolled 1,064 patients at 20 German sites, were recently published in EuroIntervention.

Abbott's MitraClip System, which received CE Mark in 2008 and is commercially available in Europe and other international markets, is an investigational device in the United States. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce MR by clipping together a portion of the leaflets of the mitral valve to allow the heart to more efficiently pump blood.

Data from Access-EU demonstrated that in real-world, post-approval experience in Europe, patients undergoing the MitraClip therapy are predominantly high surgical risk, elderly patients who are mainly affected by functional MR, a type of MR in which a damaged heart impairs the performance of a normal mitral valve. Access-EU showed that in this patient population, the MitraClip procedure demonstrated low rates of hospital mortality and adverse events and provided significant improvements in day-to-day quality of life at one year following treatment.

"I am impressed by the excellent outcomes observed in real-world patients with the MitraClip therapy. The procedure proved safe and effective even in patients who are at high risk for complications from mitral valve surgery," said Francesco Maisano, M.D., director of Transcatheter Valve Therapies at San Raffaele Hospital in Milan, Italy, lead author of the Access-EU data publication and co-principal investigator of the study. "In my experience, the MitraClip therapy has a definite role for patients who are not candidates for surgery. I have treated many patients who have experienced a dramatic improvement in quality of life. Relief from the symptoms of mitral regurgitation has allowed many bedridden patients to return to normal day-to-day activities."

"The data from these studies, which together evaluated more than 1,600 patients, add to the clinical evidence confirming positive results for treatment with MitraClip in high surgical risk patients suffering from the debilitating symptoms of significant mitral regurgitation," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "The MitraClip device represents a true advance for these patients, who suffer from poor quality of life and have no satisfactory options to reduce their significant mitral regurgitation."

Medtronic Nets FDA Clearance and 'CE' Mark for New Peripheral Angioplasty Balloon

Expanding its extensive portfolio of lesion-specific solutions for the interventional treatment of peripheral artery disease, Medtronic has announced that the Pacific Plus percutaneous transluminal angioplasty (PTA) catheter has received both U.S. Food and Drug Administration (FDA) clearance and the CE (Conformité Européenne) Mark. The launch of the new peripheral balloon catheter is underway in the United States and internationally.

Indicated for the treatment of narrowed arteries in a variety of locations within the vasculature, including the renal, iliac, iliofemoral, femoral, popliteal and infrapopliteal arteries, the Pacific Plus PTA catheter epitomises versatility. It features a hydrophilic coating for improved crossability, and enables fast deflation, which may shorten procedure time.

"Vascular specialists have been eagerly awaiting the Pacific Plus PTA catheter," said Dr. Juan Pablo Zambrano, director of cardiovascular medicine at Jackson South Community Hospital in Miami. "The device's ease of deliverability and various shaft lengths provide us with a flexible solution for both straightforward and complex cases."

Spanning a broad size matrix, the Pacific Plus PTA catheter is an over-the-wire (OTW) peripheral balloon that is compatible with both 0.014-inch and 0.018-inch guidewires and 4 French or 5 French introducer sheaths. It is available in shaft lengths of 90 cm, 130 cm and 180 cm and catheter lengths ranging from 20 mm to 120 mm for balloon diameters 2.0-7.0 mm, with a 150 mm catheter also available on balloon diameters 2.0-3.5 mm.

St. Jude Medical Initiates First US Clinical Study of the EnligHTN Renal Denervation System for Drug-Resistant High Blood Pressure

St. Jude Medical, a global medical device company, has announced U.S. Food and Drug Administration (FDA) approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure.

It is estimated that one in three American adults has hypertension, often referred to as high blood pressure—a condition that increases the risk of heart attack, stroke and kidney failure. Hypertension occurs when blood pressure in the arteries is elevated, requiring the heart to work harder than normal to circulate blood throughout the body.

“Sub-optimal blood pressure control is the most common attributable risk for death worldwide,” said Dr. William B. White, professor and chief of hypertension and clinical pharmacology in the Calhoun Cardiology Center at the University of Connecticut Health Center in Farmington, USA, and co-chair of the EnligHTN IV steering committee. “Despite the availability of several effective drugs, approximately 50 percent of patients have inadequately controlled blood pressure and eight to 12 percent are considered resistant to these medications. Renal denervation therapy may be an important advancement for these patients.”

Renal denervation is a minimally invasive therapy that may provide a lasting reduction in blood pressure for patients with hypertension who are resistant to medications. It is a specialized ablation procedure that targets nerves along the renal arteries leading to the kidneys. This intentional disruption of the nerves may cause a decrease in systolic and diastolic blood pressure.

A typical normal blood pressure is at or below 120 systolic and 80 diastolic, and is expressed as 120 / 80 mmHg. Hypertension is blood pressure greater than 140 / 90 mmHg. The risk of cardiovascular death is cut in half with every 20 mmHg decrease in systolic blood pressure.

Dr. William Gray, an interventional cardiologist at Columbia University Medical Center in New York City and co-chair of the EnligHTN IV steering committee stated, “The EnligHTN Renal Denervation System has shown tremendous promise in clinical studies outside the United States. We look forward to participating in this important study that has the real potential to change medical practice.”

The EnligHTN IV study is a randomised, single-blind, controlled, multi-center trial to demonstrate the safety and effectiveness of the EnligHTN Renal Denervation System in reducing systolic blood pressure when measured in an office setting. The study will enroll approximately 590 patients between the ages of 18 and 80 with an office systolic blood pressure of 160 mmHg or greater, who are taking three or more antihypertensive medications including a diuretic. Study patients will be enrolled at up to 80 sites in the USA and Canada.

“Researching the treatment of hypertension is one example of the ongoing investments St. Jude Medical is making to deliver high-quality, innovative products, such as the EnligHTN Renal Denervation System, which aim to reduce health care costs and improve patient outcomes,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “The EnligHTN IV study represents another important step in our commitment to advancing science, technology and clinical evidence that supports renal denervation for the millions of patients who live with uncontrolled high blood pressure.”

Medtronic Reaches Major Milestone in Clinical Program for InPact Admiral Drug-Eluting Balloon

Continuing to demonstrate its ongoing commitment to advancing interventional treatments of peripheral artery disease and the evidence to support their adoption, Medtronic has announced that enough patients have been enrolled in its clinical studies of the InPact Admiral drug-eluting balloon to support the company's U.S. regulatory approval submission of the novel angioplasty device, which is designed to treat atherosclerotic lesions in the superficial femoral artery.

In a related development, Medtronic also announced today that it plans to submit the first module of the pre-market approval (PMA) application for the InPact Admiral drug-eluting balloon to the US Food and Drug Administration (FDA) over the summer.

"The InPact Admiral drug-eluting balloon represents a novel angioplasty device from Medtronic that we foresee launching in the United States in late 2015, pending FDA approval," said Tony Semedo, president of Medtronic's Endovascular Therapies business. "It targets atherosclerotic lesions in the superficial femoral artery with a treatment modality that aims to deliver an anti-restenotic drug while leaving nothing behind."

More than 1,000 patients have been enrolled in the InPact SFA I, II, II pharmacokinetics (PK) and Global studies to date. Clinical data from these studies will comprise a significant portion of Medtronic's PMA application to the FDA for the InPact Admiral drug-eluting balloon. InPact SFA I is a European study; InPact SFA II and II PK, both US studies; and InPact Global, an international study being conducted outside the United States.

The ongoing global InPact clinical program includes 29 studies involving more than 4,600 patients at approximately 230 sites worldwide. Through these company-sponsored and physician-initiated studies, Medtronic's portfolio of InPact drug-eluting balloons will be investigated thoroughly for the treatment of arterial disease in a variety of vessel beds. As part of this program, Medtronic is currently enrolling the InPact Global study, a first-of-its-kind, "real-world" evaluation of the company's InPact drug-eluting balloons involving 1,500 patients with femoropopliteal lesions of any length at up to 80 sites worldwide.

InPact drug-eluting balloons feature a proprietary coating called FreePac that is a formulation of paclitaxel and urea, an excipient that facilitates absorption of the drug into the vessel wall. They received the CE mark in 2008 and 2009 and are available in many countries around the world.

In the United States, the InPact Admiral drug-eluting balloon is limited to investigational use under an investigational device exemption (IDE) granted by the FDA and, like every drug-eluting balloon, is not yet commercially available.

The superficial femoral artery (SFA) runs close to the surface of the upper leg, from the groin to the knee. As a result of its location, the SFA experiences a variety of torsion and compression forces that pose inherent challenges with the use of permanent metallic stents in the treatment of atherosclerosis, which causes the body's arteries to narrow with the accumulation of fatty deposits (called plaque) inside them.

In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.

Kalorama Information Publishes Global Catheter Forecast to 2017

Market research company Kalorama Information has published a report about the global catheter market, including a market forecast to 2017. The abstract for the report is as follows.

Catheters make it possible to drain or inject fluids or enable access to the body by surgical instruments. In most instances, a catheter is a thin, flexible tube, though there is great diversity in catheter types and applications. This report provides descriptions of the types of catheters and estimates their market size and discusses the competitive activity in each category. Among the catheters used in urological applications are the Foley and the urethral catheters. Cardiovascular catheters find use in cardiac catheterisation. This is a minimally invasive procedure in which a catheter is guided into the heart, usually through a blood vessel in the leg or arm. Once inside the heart, it can be used for diagnosing or treating a condition. Intravenous catheters are used if a person requires frequent or continuous injections of medications or fluids for nutritional support. A wound drain catheter is inserted while a patient is in the operating room receiving general anesthesia. The purpose of the drain is to remove fluid or blood from the surgical site. This helps the healing process.

Increased life expectancy and subsequent aging of the global population play a key role in the rising demand for all types of medical catheters. Companies seeking opportunities in this medical device market will want to utilize Kalorama Information's World Market for Catheters. This report is a comprehensive look at the market of these critical medical devices. Which segments of catheters provide the most opportunity? Which are growing the fastest? Who are the key players and what share do they have of the market? What are the critical issues and trends that will drive catheter sales in the future. What pitfalls do manufacturers need to be aware of? These questions and more are answered in this report.

This report contains global market size and forecast to 2017 for the following types of catheters:

For many of these segments, company market share and regional breakout for US, Europe and Rest of World is provided. In addition to numbers that can be useful for business planning, the report provides analysis of the industry, including analysis of several important trends. Trends discussed in this report include the following:

As part of Kalorama Information's information-gathering process, executives were interviewed and their insights provided the commentary of this report. Company profiles are included, with profiles of the following companies:

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