BB&T Senior Staff Writer and Staff Reports

InfraReDx (Burlington, Massachusetts), a company developing cardiovascular diagnostic imaging technologies, said it has received FDA 510(k) clearance to market its LipiScan IVUS coronary imaging system.

According to the company, the device is the first cardiac catheter to combine intravascular ultrasound (IVUS) and near-infrared (NIR) spectroscopy to help cardiologists identify and characterize the plaques that complicate stenting and are associated with acute coronary events.

The NIR spectroscopy identifies the chemical content of the plaques, James Muller, MD, founder/CEO and chief medical officer of InfraReDx, told Biomedical Business & Technology. The IVUS provides an image of plaque structure and stent features, he explained.

The company expects to conduct a broad commercial launch of the system within the U.S. by the end of the year, and anticipates regulatory approval and launch in Europe in 2011.

InfraReDx's first-generation LipiScan NIR system is already in use at about 25 cardiac centers in the U.S. and is the only FDA-cleared device for the detection of lipid core coronary plaques (LCP), according to the company. Muller said LCP is a fatty coronary artery plaque known to complicate stenting and suspected to cause most heart attacks following stenting. The addition of IVUS imaging enhances the value of LipiScan by providing visualization of the coronary artery lumen, assessment of the structural features of coronary plaque, and identification of proper stent sizing and expansion, the company noted. The LipiScan IVUS system's design provides physicians with a grayscale IVUS image of the coronary artery along with a complete and co-registered chemogram – a map of LCP within the imaged vessel.

“We are pleased to have achieved the important milestone of FDA marketing clearance for LipiScan IVUS, our multi-modality, single-catheter device that provides improved characterization of coronary plaques,“ Muller said. “Interventional cardiologists adopting the LipiScan IVUS system will be able to quickly and accurately identify the presence and structural features of lipid-core plaques in the coronary arteries. Such knowledge will assist them in the conduct of the stenting procedure and provide information useful in the treatment of patients post-stenting.“

Muller formerly served as a professor of medicine at Harvard Medical School (Boston) where he conducted research for more than 25 years on the causes of heart attacks. In 1989 he introduced the term “vulnerable plaque“ to describe those plaques likely to rupture and lead to a heart attack.

“Many people believed that lipid-core plaques were vulnerable plaques,“ Muller told BB&T. In 1998, nearly 10 years after the concept behind the device was born, he founded InfraReDx. “It took 10 years to build the NIR spectroscopy system.“

According to Muller, the NIR spectroscopy device is a “very powerful way to detect“ the chemical content of the plaques, but it's a “terrible way to find the structure of the plaques.“

That's why the development of the LipiScan IVUS coronary imaging system is so unique, Muller said, because it combines the benefits of NIR spectroscopy with IVUS imaging.

InfraReDx expects physician adoption of this new system to be fairly rapid.

“We're getting more demands from the system from around the world than we can meet,“ Muller said. Later he clarified that the company does not have back orders of the system, but rather has simply had “more interest“ in the system than it can meet right now.

When asked about the challenges that InfraReDx had to overcome to develop the LipiScan imaging system, Muller said finding a way to access the heart was the biggest challenge.

“What was hard and took 10 years was [figuring out] how [to] make that chemistry lab measurement inside the human coronary, which is beating and full of blood and hard to get to,“ Muller said.

The next challenge was figuring out how to make the system function through blood and while the heart is beating. “The heart is bouncing,“ Muller explained. “It's a lot like taking a photograph of a runner - you need to take a fast photo; so we had to take fast photo.“

Those, along with other challenges, took a team of more than 30 engineers – some of them working for a decade - to solve. Next, the company had to develop a method of doing ultrasound through the same catheter so they had to fill the catheter with saline for the sound to travel through. Once that was accomplished, the researchers had to prove that it didn't mess up the NIR part of the device.

Then, of course, there was the challenge of funding the project.

“We had to find investors that were willing to invest in something that was going to be difficult to build, that would take a long time, [but that] could make a big difference for patients,“ Muller said.

Elsewhere in the product pipeline:

• Abiomed (Danvers, Massachusetts) reported that the first patient was successfully supported for six days by the Impella Right Peripheral (RP) at the Providence Heart + Lung Institute at St. Paul's Hospital (Vancouver, British Columbia). The Impella RP is a percutaneous catheter-based axial flow pump. It is inserted via a single access vessel and does not require the patient's chest to be opened. It is passed through the right ventricle and delivers greater than four liters of blood flow from the lower right atrium to the pulmonary artery. Patients with right ventricular dysfunction or right heart failure, lack blood flow from the right side of their hearts. The Impella RP is designed and intended to provide the flow and pressure needed to compensate for right heart failure. Right heart failure can occur either as an isolated event or can be associated with left heart failure when the patient is suffering from biventricular failure. Abiomed said, with the Impella, cardiologists and surgeons will be able to treat right heart dysfunction without opening the patient's chest or requiring another surgery. Some patient populations that could potentially benefit from percutaneous right-sided support are: post operative right ventricular dysfunction following transplant, LVAD placement for heart surgery, cardiogenic shock, isolated right side failure from chronic heart disease, and elevated pulmonary artery blood pressure following pulmonary embolism.

• B. Braun Aesculap (Center Valley, Pennsylvania) a supplier of battery operated surgical motor systems presented the latest version of the Acculan 3Ti battery powered motor system for use in orthopedics and traumatology as well as cardiothoracic surgery. The Acculan 3Ti provides 250 watts of power during surgical procedures. The durability of a battery powered motor system depends decisively on the reliability of the battery pack. Aesculap says the Acculan 3Ti electronics control is held within the detachable battery pack, which avoids steam sterilization of the heat-sensitive battery cells and electronic components, thus extending the lifetime of the battery and reducing the hospital's operational costs. The company also says that the Acculan 3Ti offers the kind of performance previously found only in pneumatic or cable systems. Operation modes of the Acculan 3Ti include: drill mode clockwise, drill mode counterclockwise, oscillating and tapping mode. The battery charger automatically checks the condition of the battery after each charging cycle and indicates when a battery shows declining performance and should be replaced.

• Bruker (Billerica, Massachusetts) reported the introduction of the Icon, a 1 Tesla desktop MRI scanner designed to bring preclinical magnetic resonance imaging (MRI) within reach for a broader range of molecular imaging laboratories. The system contains a cryogen-free permanent magnet from Aspect Magnet Technologies and Avance III spectrometer technology with preclinical MRI software ParaVision from Bruker. The company claims that even with a field strength of 1 Tesla, the Icon has zero magnetic fringe field enabling safe location of the system in any facility and for use by any operator. No additional magnetic or RF shielding is required for the implementation in the lab.

• Cerus (Concord, California) reported the successful outcome of a multi-year trial of Intercept-treated platelet components conducted at the Swiss Red Cross Blood Center in Basel, Switzerland. The Intercept blood system is a pathogen inactivation treatment designed to protect against transfusion-transmitted diseases. The Intercept system is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action allows Intercept treatment to inactivate both established transfusion threats, such as hepatitis, HIV, West Nile virus and bacteria, as well as emerging pathogens such as influenza, malaria and dengue.

• ConvaTec (Skillman, New Jersey) reported the introduction of a new, narrower size of Aquacel and Aquacel Ag ribbon dressings with strengthening fibers, now available in the U.S. and select European countries for the management of moderate to highly exuding chronic and acute wounds. The new dressing, half the width of the currently available dressing, is designed specifically for use in excised abscesses and smaller wounds that tunnel below the wound surface.

• Havel's (Cincinnati) reported the release of a new echogenic ultrasound needle which could help reduce radiation exposure. The company released four new echogenic needles using its Micro Laser Etching (MLE) technology, which creates multiple angled surfaces to reflect sound waves back to the transducer even at steep insertion angles. The new needle, the Echogenic EchoTuohy Epidural Needle, will be used for ultrasound-guided peripheral nerve blocks, epidural catheter placement, and epidural steroid injections. With the MLE technology, users are free to pass wires or catheters through the cannula without obstruction, the company said.

• IRIS International (Chatsworth, California) received FDA clearance for the analysis of synovial fluid as a new product application in its Body Fluids Module utilizing its iQ 200 and iRICELL automated microscopy analyzers. Synovial fluid is a highly viscous material that is present in many of the joints of the body. It serves the purpose of lubricating and nourishing certain parts of the joint. Synovial (joint) fluid analysis may be ordered to help diagnose the cause of joint inflammation, pain, swelling, and fluid accumulation, associated with such disorders as acute and chronic septic arthritis due to bacterial infection, autoimmune disorders including rheumatoid arthritis and systemic lupus erythematosus, and degenerative diseases such as osteoarthritis. The body fluids module for automated body fluids analysis is offered as a separate software option for the iQ200 analyzer and is expected to generate incremental recurring revenue through the use of the company's consumables. This application enables a laboratory to analyze a suite of body fluids and urine samples on its existing iQ200 instrument using the company's digital imaging technology.

• K2M (Leesburg, Virginia) received FDA clearance to market its new Chesapeake anterior-lumbar stabilization system, an interbody device designed for stabilization of the spine through an anterior approach. The system provides screw fixation through K2M's tifix locking technology, whereby each screw head forms an autogenic lock to the implant upon insertion. Chesapeake, an implant manufactured from biocompatible PEEK polymer, allows for anterior stabilization and fixation with a zero-profile design. Additionally, the system uses an anterior insertion ramp, which allows for parallel distraction and controlled threaded insertion while applying a zero-impact load on the interbody.

• Ovatech (Auburndale, Massachusetts) said that the company's phase II clinical study of its non-hormonal, intravaginal contraceptive ring, Ovaprene, has been successfully completed. Ovaprene is a 'one-size-fits-all' patented, female-controlled, intravaginal organic silicone ring barrier-contraceptive that is designed to continuously release spermiostatic and spermicidal non-drug agents over a four-week period. In the phase II study, 85 females participated and were instructed in the proper insertion of the one-size-fits-all Ovaprene ring at completion of menses – with removal at onset of subsequent menses; this protocol was observed once a month for three months for each study participant. All Ovaprene rings were retained in place, including post-coitus. Ovaprene is designed to offer a non-systemic, female-controlled birth control option – without the need for partner consent or approval. Contraceptives and contraceptive devices are likely the most widely used medical devices in the world, with $22 billion spent on contraception in the U.S. market annually. Ovatech is an emerging medical technology company that is focused on products to enhance women's health.

• Prometheus Laboratories (San Diego) reported the launch of the Prometheus Crohn's Prognostic test. This diagnostic is expected to advance the Prometheus Inflammatory Bowel Disease (IBD) franchise of diagnostic and prognostic tests, and complements the Prometheus IBD Serology 7. The Prometheus Crohn's Prognostic test combines six serologic markers and three genetic mutation markers to provide physicians with a personalized serogenetic profile for their patients. This should help enable physicians to quantify these patients' risk of developing disease complications and is designed to provide information to assist physicians in determining optimal treatment strategies for their Crohn's patients.

• Pyng Medical (Vancouver, British Columbia) received FDA clearance to market the FASTx sternal intraosseous device. The company will now begin ramping up production to meet the anticipated demand for this next generation IO product. The FASTx device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) that require vascular administration of drugs or fluids to facilitate emergency resuscitation. The company said the FASTx is a safe alternative to conventional IV infusion, providing lifesaving vascular access for fluid and drug resuscitation in shock and trauma victims.

• Terumo Medical (Somerset, New Jersey) reported the first U.S. patient implant in the Occlusive/Stenotic Peripheral artery REvascularization StudY (OSPREY) trial, which will evaluate the safety and efficacy of its Misago Peripheral Self-expanding stent system for use in the superficial femoral artery (SFA). The primary endpoints of the U.S. study are: Primary stent patency rate at one year as confirmed by duplex ultrasound or angiography; freedom from major adverse events within 30 days of the procedure, which would result in target lesion revascularization, amputation of the treated limb or death. The Misago stent system consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system. The stent has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion. The design distributes the dynamic superficial femoral artery stress loads throughout the stent's struts providing not only flexibility, but also durability against bending, compression, and torsion, the company said.

• USGI Medical (San Clemente, California) said that updated multi-center results confirm durability of the company's Expandable Tissue Anchors up to a year or more in a variety of incisionless gastrointestinal (GI) procedures, including use of a ROSE procedure (Repair of Surgery, Endolumenal) to repair dilated tissue after gastric bypass. These findings, the company claims, demonstrate long-term, secure-tissue approximation with this scarless “through the mouth“ approach in the largest cohort of patients ever reported, underscore the use of the company's Incisionless Operating Platform (IOP) and these anchors for durably suturing GI tissue. USGI says surgeons are using the IOP to perform ROSE in a number of applications, including repair of dilated stomach pouches and stomas after gastric bypass surgery, repair of gastro-gastric fistulas (a common complication that arises after Roux-en-Y gastric bypass), and slipped Nissen fundoplications for GERD. To perform these procedures, surgeons pass the flexible USGI IOP down a patient's throat and use these tools to grasp tissue and deploy the Expandable Tissue Anchors to create desired tissue folds that re-shape the stomach or close incisions in the stomach. An endoscope provides visualization during the procedures.

• Viking Systems (Westborough, Massachusetts) has received FDA clearance related to its 3DHD visualization system. The system is scheduled for market launch at this year's American College of Surgeons' Annual Clinical Congress which will be held in Washington from Oct. 3-7. Viking claims the 3DHD system provides surgeons from a broad base of surgical specialties with the ability to perform complex minimally invasive surgery with a revolutionary vision system that restores their natural depth perception previously sacrificed with 2-D systems. Viking's 3DHD system is planned to offer surgeons the choice of two different proprietary 3-D optical systems. The company said it also plans to offer a 2DHD camera for use with the system for surgeons that may prefer this modality for less complex cases. Viking Systems makes 2-D and 3-D visualization solutions for complex minimally invasive surgery.