The FDA approved a humanitarian device exemption (HDE) for fetoscopy instrument sets distributed by Karl Storz Endoscopy America (Culver City, California) under the Humanitarian Use Device (HUD) program for the treatment of fetuses with twin-to-twin transfusion syndrome (TTTS). TTTS, according to the FDA, is a rare disorder of the placenta that sometimes occurs when women are pregnant with identical twins. In TTTS, during the development of the twins, blood vessels in the fetuses’ shared placenta connect their blood circulations. In TTTS, the blood begins to flow unevenly, with one fetal twin receiving too much blood, which is called the “recipient,” and one receiving too little, the so-called “donor.”
The FDA said that many such TTTS babies do not survive delivery or are born with severe handicaps. “This medical device gives doctors a new option for treating twin-to-twin transfusion syndrome,” said Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health. “It can help prolong the mother’s pregnancy and improve the odds of survival, with reduced complications, for one or both twins.”
A Karl Storz spokesman told Cardiovascular Device Update that the system is actually a set of instruments called a “fetoscopy instrument set.” It consists of a fetoscope, which is one of the company’s endoscopes with a light attached that is used to view the fetus. The endoscope also includes a sheath which is used to enter the abdomen of the mother through a small incision. That incision is used to pass through surgical instruments and, if necessary, any fluid. The device set is intended for use for fetuses whose gestational age is between 16 and 26 weeks. “That’s sort of the access point,” the spokesman said. “This is minimally invasive, of course.” The third component of the procedure, which is not carried out by the instrument set, is a laser, previously FDA-approved, that can be used as a “heat source to coagulate tissue, and this is what actually forms the treatment for this condition,” he said.
Essentially, while being guided by ultrasound in the woman’s abdomen, the physician can determine exactly where the problem blood vessels involved in TTTS are located. “Once they identify those, they can insert the laser and they use the photocoagulation function to heat up the tissue, and this essentially destroys a portion of the blood vessel, which is how they treat the condition,” the company spokesman said.
In other products news:
• Angiotech Pharmaceuticals (Vancouver, British Columbia) said an article in the March 15 edition of the Journal of the American Medical Association on the TAXUS V ISR (in-stent restenosis) clinical trial reported that the Taxus Express2 paclitaxel-eluting stent system, made by Angiotech’s partner, Boston Scientific, achieved superior outcomes in the treatment of in-stent restenosis compared to those patients treated with radiation-based brachytherapy. TAXUS V ISR showed that compared with brachytherapy, implantation of paclitaxel-eluting stents reduced the nine-month rate of target vessel revascularization from 17.5% to 10.5% and target lesion revascularization rate from 13.9% to 6.3%. The study also demonstrated an 11.5% rate of major adverse cardiac events for the Taxus stent group, as compared to a 20.1% rate for the control group.
• Biotronik (Portland, Oregon), focused on cardiac rhythm management, reported FDA approval and the first implant of the newest member of its Biotronik implantable cardioverter defibrillator lead family, the Linox SD active fixation, steroid-eluting lead. The Linox SD incorporates a slim 7.8 Fr isodiametric lead body, an advanced helix mechanism, and two color-coded DF-1 connectors. Linox SD also features Biotronik‘s fractal technology for improved sensing performance and a steroid-eluting collar to control acute threshold increases. The first U.S. implantation of Linox SD was performed at Riverview Regional Medical Center (Gadsden, Alabama) on April 10. The company said it also recently received FDA approval for the Setrox S active fixation, steroid-eluting bradycardia lead. It features a slim isodiametric profile at 6.7 Fr with the same advanced helix mechanism and flexible distal tip that provides greater maneuverability for implantation and improved post-implantation results. Both Linox SD and Setrox S offer great mapping capability that allows physicians to identify the optimal implant location prior to extension of the helix, the company said.
• Boston Scientific (Natick, Massachusetts) reported the U.S. launch of its ZIPwire Hydrophilic Guide Wire, which has received FDA clearance to facilitate the placement of devices during diagnostic and interventional procedures. The ZIPwire Guide Wire’s coating supports smooth exchanges with other devices and is designed to support crossing of difficult lesions. A flexible and refined tip is designed to allow physicians to maneuver through tortuous blood vessels and facilitates smooth catheter advancement and precise positioning. A robust nitinol core resists kinking and transmits rotation along the length of the device (torque transmission), which improves maneuverability. The ZIPwire Guide Wire is available in stiff and standard versions and in various lengths, diameters and tip shapes.
• Cardiac Science (Bothell, Washington), a manufacturer of advanced cardiac monitoring and defibrillation products, reported that it has secured three new U.S. patents. The first patent covers an external defibrillation module for integration into standard hospital patient monitors. The module has numerous modes of operation and is designed for integration with generic patient monitoring equipment to share certain functions and provide patients with the appropriate anti-tachycardia therapy. The second covers a publicly available portable defibrillator capable of being used by a bystander to automatically deliver life-saving defibrillation shock to a heart attack victim. The third patent covers a method of microvolt T-wave Alternans testing, a noninvasive testing method that employs statistical analysis to identify microvolt abnormalities in a patient’s electrocardiogram in order to determine a patient’s vulnerability to sudden cardiac arrest.
• CardioDynamics (San Diego), a developer of impedance cardiography (ICG) technology, reported publication of data from the ED-IMPACT trial, which demonstrated that information from its BioZ ICG device resulted in a change in treatment 39% of the time and a change in emergency department diagnosis 13% of the time in patients presenting with shortness of breath. The results were published online in Academic Emergency Medicine, and will be published in the print version of the journal in April.
• Cardiogenesis (Foothill Ranch, California), manufacturer of surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) procedures, reported the publication of an Expert Review of Medical Devices focused on the company’s Holmium:YAG TMR system in the March edition of Future Drugs. Author Keith Allen, MD, of the Heart Center of Indiana (Indianapolis), concluded: “Angiogenesis is the most likely mechanism of action responsible for clinical improvement following TMR, and research should be continued to find ways to augment this process.”
• Cordis (Miami Lakes, Florida) said one-year follow-up data from the largest completed drug-eluting stent registry, consisting of more than 15,000 patients, found that the Cypher Sirolimus-eluting Coronary Stent demonstrates the same level of safety and efficacy in clinical practice as in randomized, controlled clinical trials. The results were published in the March 21 issue of Circulation. Specifically, the e-Cypher Registry found that real-world treatment with the Cypher stent in a wide range of patients – including a large number of patients with diabetes (28.6%) – resulted in low rates in the need for repeat procedures, major adverse cardiovascular events such as heart attack and death, and in-stent blood clots. The e-Cypher Registry is the largest Internet-based post marketing surveillance registry to be completed of its kind and is designed to assess the safety, efficacy and reliability of the Cypher stent in daily clinical practice.
• CryoCath Technologies (Montreal), manufacturer of cryotherapy products to treat cardiovascular disease, said it intends to expand the feasibility stage of its STOP AF trial by enrolling an estimated 15 additional patients. This trial is assessing the company’s Arctic Front catheter to treat atrial fibrillation. Arctic Front’s revised design incorporates improvements implemented following the start of the feasibility stage, including two balloon sizes, based on physician feedback from clinical use in Europe and the U.S. As a result of these collective changes, the FDA has requested more patients be treated prior to the start of the pivotal portion of the U.S. investigational device exemption trial. The company said the beta-launch of Arctic Front in Europe continues to progress well, with more than 100 procedures performed. Chronic success data on a substantial number of patients were presented at the German Cardiac Congress in Mannheim, Germany, late last month.
• Masimo (Irvine, California) reported FDA clearance of the Rainbow SET Rad-57cm Pulse CO-Oximeter, a hand-held, continuous monitor that analyzes data from 8-wavelength finger sensor to measure arterial oxygen saturation, carbon monoxide, methemoglobin and pulse rate. Building on Masimo’s Rad-57 launched in 2005, the Rad-57cm adds the ability to measure methemoglobin, which compromises the blood’s ability to carry oxygen and can be life-threatening.
• A research team at the Mayo Clinic (Rochester, Minnesota) used a noninvasive tool, called an arterial tonometer, to discover an association between stiffness in arteries and the presence and amount of coronary artery calcium, which the clinic said could lead to the accurate assessment of heart disease risk in adults with no symptoms. The lead author of the study said that the test is for people determined to be at intermediate risk based on risk factors outlined by the guidelines published by the National Cholesterol Education Project and assessed a score based on the Framingham Risk Score.
• Medtronic (Minneapolis) reported FDA clearance of expanded labeling for its cardiac resynchronization therapy (CRT) biventricular pacing systems. The labeling revision reflects new clinical benefits of Medtronic CRT systems including reduced risk of all-cause mortality and unplanned heart failure or cardiovascular hospitalization, along with previously established outcomes of patients’ reduction in NYHA Class, improved quality of life, and improved exercise capacity, among others. The FDA’s labeling expansion was based on the results of CARE-HF (Cardiac Resynchronization in Heart Failure), a landmark clinical study sponsored by Medtronic. The study results, first presented during the American College of Cardiology conference in Atlanta, and concurrently published in The New England Journal of Medicine, demonstrated that CRT reduces hospitalizations and saves lives in many patients with moderate or severe heart failure and poor heart pumping function. In the study, CRT was shown to reduce all-cause mortality by 36% and unplanned hospitalizations for worsening heart failure by 52%.
• Nanogen (San Diego), developer of advanced diagnostic products, reported that it has received FDA 510(k) clearance to market its StatusFirst CHF NT-proBNP EDTA plasma test to aid in the diagnosis of individuals suspected of having congestive heart failure (CHF). The StatusFirst CHF product results from collaboration between Nanogen and Princeton BioMeditech (PBM; Princeton, New Jersey), a rapid diagnostic test manufacturer. Nanogen and PBM have co-developed and will co-market the product. PBM will manufacture the product under contract with Nanogen. The StatusFirst CHF test is sold in conjunction with the DXpress reader, a qualitative and quantitative instrument supplied by PBM.
• St. Jude Medical (St. Paul, Minnesota) reported FDA approval and launch of its next generation vascular closure device, the Angio-Seal VIP. The new device, which is approved for both diagnostic and interventional procedures, gives physicians an improved method for sealing arterial catheterization access sites. Because it provides more coverage on the artery surface than previous devices, physicians may more effectively achieve hemostasis, the company said. The device’s coated suture enhances physicians’ ability to effectively seal access sites. If physicians need to access the site a second time, they can safely re-enter with the Angio-Seal VIP device within 1 cm of the original site. All components, including a small anchor, collagen and a suture, of the Angio-Seal VIP are fully absorbed within 60 to 90 days.
Separately, St. Jude reported FDA approval and market launch later this month of the Riata ST lead, which it said is the thinnest implantable cardioverter defibrillator (ICD) lead at 6.3 French. The device also introduces isodiametric defibrillation coils, intended to prevent tissue in-growth and allow for easier explants. The lead provides steroid-elution, a time-released delivery of a steroid near the pacing electrode, intended to improve the long-term pacing threshold. It is available in a true bipolar version, and in an integrated version. The Riata ST lead will be available in single-coil and dual-coil versions, as well as 17 mm and 21 mm tip-to-proximal coil spacing. Its multi-lumen leads feature a modern titanium tip housing with radiopaque markers designed for better visibility during implantation procedures. The Riata ST lead is available in six active-fixation models, which attach in the heart using an extendable-retractable helix mechanism, and six passive-fixation models. The lead features a silicone insulated body designed for greater flexibility, along with Fast-Pass coating to promote ease of movement.
• WorldHeart (Oakland, California), a developer of mechanical circulatory support systems, reported that its next-generation pulsatile left ventricular assist system (LVAS), the Novacor II, has entered a key phase of animal testing on the development pathway toward human trials. The Novacor II LVAS is the only small, bearingless next-generation pulsatile ventricular assist device in development. The blood pump is driven by direct magnetic actuation, eliminating any components subject to wear and promising enhanced long-term durability. The company said it plans to conduct a series of animal implants in this preclinical stage over the next 15 months.