While much of the focus thus far in evaluating the connection between refractory migraines and patent foramen ovales (PFOs) has been concentrated on a few companies – including NMT Medical (Boston), AGA Medical (Golden Valley, Minnesota) and St. Jude Medical (St. Paul, Minnesota) – that are developing permanent implantable device technology to close the common heart defect, a few companies are quietly working on a ’ minimally invasive treatment for the condition in which no device is left behind after the surgery.
One player exploring this new no-device-left-behind approach for PFOs is privately held Cierra (Redwood City, California), via its PFx Closure System, which was conceptualized and initially funded by the well-known medical device incubator, The Foundry (also Redwood City), beginning in January 2003.
At the time of Cierra’s genesis, according to Erik Engelson, president and CEO, it was decided that the company initially would go for an approval in the refractory migraine market rather than the stroke market, which was what PFO closure devices were first designed to treat. “The Foundry identified PFO as an opportunity,” Engelson told Biomedical Business & Technology, and after looking at the stroke opportunity for PFOs, “decided that was a long clinical study and the two companies in that, NMT and AGA, had been having trouble enrolling patients.”
It was decided that migraine was a better business model for the company, especially since “some of the retrospective work in migraines looked very compelling.” Indeed, there are an estimated 2.2 million migraine sufferers with PFO and aura in the U.S., and retrospective studies have shown that closing a PFO can reduce migraine attacks. Of that number, an estimated 750,000 could possibly benefit from PFO closure, resulting in a market potential of nearly $3 billion in the U.S. alone.
The procedure, like those done by other players in the treatment of PFO that leave an implant behind, is performed by an interventional cardiologist in the catheterization lab. During the procedure, a guidewire is introduced via the right femoral vein to cross the PFO for balloon sizing and device placement. Next the company’s PFx catheter is advanced into the right atrium over the guidewire and once the device is in place, suction is introduced to tightly close the PFO and hold the PFO tissue against the inside of the device. Radio frequency energy then is applied to the suctioned area to “weld” the tissues of the PFO closed, with the entire procedure taking about 30 minutes to complete.
Not having an implant in the body after surgery presents several advantages, Engelson said. Some adverse events that he said are associated with implants include atrial fibrillation, which is reported in up to 12% of cases. Additionally, he noted that heart palpitations have been reported in up to 65% of patients and there also is the very real threat of thromboembolic issues.
Elsewhere in the product pipeline:
• The first U.S. multicenter, prospective clinical trial to investigate the use of minimally invasive stent placement to treat severe peripheral arterial disease (PAD) below the knee has been cleared by the FDA, with its approvals of an investigational device exemption (IDE) filed by the study’s sponsors. The study, sponsored by Viva Physicians (VPI; Rosemont, Illinois) and supported by a restricted educational grant from the maker of the stent, Abbott Laboratories (Abbott Park, Illinois), will be the first in the U.S. to evaluate the Xpert expandable nitinol stent in the blood vessels below the knee. The Xpert already is cleared in the U.S. to treat blockages in the biliary ducts that carry digestive enzymes from the liver. VPI submitted its IDE application to study the stent’s use in the popliteal and tibial arteries below the knee to the FDA in February. The primary endpoint of the XCELL study is avoidance of major amputation at 12-month follow-up after treatment.
• Acusphere (Baltimore) reported the completion of enrollment in the second of its two Phase III clinical trials, RAMP-2 (Real-time Assessment of Myocardial Perfusion-2), for the company's lead product candidate, AI-700. AI-700 is an investigational ultrasound contrast agent designed to assess myocardial perfusion. Currently there is no approved ultrasound contrast agent to assess blood flow to the heart muscle. The company said it anticipates making a public announcement regarding the RAMP-2 trial results in 4Q06. Separately, the company reported results for the RAMP-1 clinical trial and an intellectual property license with GE Healthcare (Waukesha, Wisconsin). The company’s trials of AI-700 are designed to demonstrate that stress echo with AI-700 is non-inferior to nuclear stress testing in the detection of coronary heart disease.
• ArthroCare (Sunnyvale, California) said two new studies show that coblation devices were effective for safely treating symptomatic chondral defects in the knee. The studies were presented at the recent Arthroscopic Association of North America meeting in Hollywood, Florida. Coblation is ArthoCare’s technology that combines bipolar radio frequency energy with a saline solution to gently and precisely remove soft tissue at low temperatures. The first study evaluated in vivo histologic findings after the use of bipolar radio frequency-based methods in articular cartilage of the knee. Results of the study indicate this approach can be used to safely treat grades II and III lesions in the knee. A second study, Osteonecrosis Following Arthroscopic Chondroplasty – a Retrospective Evaluation of 521 Patients Who Underwent Arthroscopic Knee Surgery – indicated no relationship between the onset of osteonecrosis and the type of surgical device used for treating symptomatic chondral defects in the knee.
• Aspect Medical Systems (Newton, Massachusetts) said that findings from two studies presented at the annual meeting of the American Psychiatric Association document the capability of its EEG-based research technology to predict an individual’s likelihood of responding to treatment of depression with an SSRI at one week after initiating medication. The studies, conducted at Massachusetts General Hospital (MGH; Boston) and Cedars Sinai Medical Center (Los Angeles), were designed to assess whether Aspect’s technology can accurately predict treatment efficacy in major depressive disorder. In the MGH open-label SSRI study, Aspect’s technology predicted eight-week clinical response at one week into treatment with 86% accuracy in the subset of subjects who receive no dose changes after the week 1 EEG assessment, and 73% accuracy across all 84 study subjects. In the 26 subject Cedars-Sinai study, the technology predicted eight-week patient response to citalopram with 81% accuracy. The predictive accuracy was higher (88%) in the eight subjects whose citalopram dosage remained constant following the one-week EEG assessment.
• BioForm Medical (San Mateo, California), a developer of injectable implant products for soft tissue augmentation, reported the results of a clinical study confirming the long-term efficacy of Radiesse for the treatment of vocal fold insufficiency. Radiesse, a non-surgical vocal fold treatment, demonstrated success in improving the voice of patients for 12 months without surgery. New study data showing that 73% of study patients reported their voice was greatly or significantly improved 12 months after Radiesse treatment were presented during the recent Combined Otolaryngology Spring Meetings in Chicago. The company said this investigation is the largest multicenter, open-label, prospective clinical study of its kind in the field of voice disorders.
• Biotronik (Lake Oswego, Oregon) said it received approvable status from the FDA for the Kronos LV-T Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Corox OTW Coronary Sinus lead, which complete Biotronik’s pioneering Heart Failure Therapy System. The Kronos LV-T is a CRT defibrillator offering a wireless heart failure monitor for continuous tracking and monitoring of the status of heart failure patients. Six proven variables are automatically tracked and trended daily. Through Home Monitoring, the Kronos automatically transmits intracardiac electrograms via radio frequency communications and allows the physician to view this vital patient information on a secure web site. The Corox OTW coronary sinus lead offers low acute and chronic thresholds averaging below 1 V. The Progressive Curve configuration of the Corox OTW means the lead coils distinctively at the tip, with a more relaxed curvature further from the apex, when the guide wire or stylet is removed. The primary advantage of this configuration is secure fixation in a wide range of vein diameters. The second key attribute is that the electrode is positioned against the wall of the vessel, which Biotronik said leads to lower acute and chronic LV thresholds than competitors’ CS leads.
• Boston Scientific (Natick, Massachusetts) said that results of a clinical trial designed to study unnecessary pacing in recipients of an implantable cardioverter defibrillator (ICD) were presented at the Heart Rhythm Society meeting in Boston. The trial, INTRINSIC RV (Inhibition of Unnecessary Right Ventricular Pacing with AV Search Hysteresis in ICDs), was designed to advance the company’s understanding of a proprietary feature that minimizes unnecessary right ventricular pacing in patients who received the company’s market-released dual-chamber ICD. INTRINSIC RV is a multicenter, randomized trial enrolling more than 1,500 patients in the U.S., Germany, Italy and Australia. Nine hundred eighty-eight patients with mild and moderate pacing requirements were randomized to either atrial support pacing or ventricular only pacing groups. The trial used Boston Scientific’s AV Search Hysteresis feature, which has been incorporated in all the company’s dual-chamber ICDs since June 2000. Separately, Boston Scientific (reported that it has received FDA clearance to launch its Sterling Monorail and Over-the-Wire Balloon Dilatation Catheter in the U.S. The balloon catheters are available in a broad range of sizes. Both balloon catheter platforms are engineered for use in the renal and lower extremity arteries, as well as in dialysis fistula. In addition, the Sterling Monorail Catheter received a specific indication for use in the carotid arteries as both a pre- and post-dilatation balloon. The Sterling Balloon Dilatation Catheter features an ultra-low profile balloon (4 Fr), designed to meet the challenges of the peripheral vasculature. Its refined profile is complemented by a balanced shaft featuring seamless transitions, which the company said is designed to offer clinicians enhanced trackability and powerful push when faced with traversing challenging anatomy.
• CardioDynamics (San Diego), a provider of impedance cardiography (ICG) technology, reported publication of the company's PREDICT (Prospective Evaluation and Identification of Decompensation by ICG Test) study, demonstrating a significant relationship between BioZ ICG parameters and the occurrence of near-term major heart failure events. The results were published online in the Journal of the American College of Cardiology and also in the June print version of the journal. “The PREDICT results suggest that when performed at regular intervals in stable patients with heart failure with a recent episode of clinical decompensation, ICG can identify patients at increased near-term risk of recurrent decompensation,” said Milton Packer, MD, of the University of Texas Southwestern Medical Center (Dallas), principal investigator of the study and lead author on the paper.
• Cepheid (Sunnyvale, California), a broad-based molecular diagnostics company, reported the European release of the Smart VZV Assay for clinical diagnostic use on the SmartCycler System. The VZV assay was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Smart VZV is intended for rapid detection of the varicella-zoster virus, a member of the herpes virus subfamily. Cepheid’s Smart VZV delivers a positive or negative result in under an hour after DNA extraction.
• Concentric Medical (Mountain View, California) and the SITS Network (Stockholm, Sweden) reported their partnership on the THRUST (Throm-bectomy in Unsuccessful Stroke Thrombolysis) study, to be sponsored by Concentric Medical and managed by the SITS Network. The study is anticipated to begin enrolling patients later this year, and will investigate the Merci Retrieval procedure in ischemic stroke patients who fail standard thrombolytic therapy. THRUST will compare the clinical outcome of patients treated with mechanical thrombectomy using the Merci Retrieval System vs. patients with no further intervention. Concentric Medical is focused on developing new stroke treatments, while the objective of the SITS Network is the broad implementation and amplification of evidence-based stroke treatments.
• Cyberonics (Houston) said that the first nine patients have been enrolled in a year-long Vagus Nerve Stimulation (VNS) Therapy dosing study that will examine treatment outcomes for patients with treatment-resistant depression (TRD) who are randomized to three different doses of VNS Therapy. About 460 patients at 30 study sites will be enrolled in the multicenter, double-blind study. The company said data collected from the study will provide guidance to psychiatrists regarding the relationship between dosage and efficacy for treating patients with VNS Therapy. VNS Therapy is the first FDA-approved implantable device-based treatment for depression and the first treatment developed, studied, approved and labeled specifically for patients with TRD.
• Endologix (Irvine, California), which manufactures minimally invasive treatments for vascular diseases, reported receipt of FDA approval to begin marketing its next-generation Visiflex Delivery System for use with the Powerlink System for the minimally invasive treatment of abdominal aortic aneurysm. The company said it plans to introduce the Visiflex in the U.S. market through a controlled launch program to further develop targeted physician feedback and to build inventory, with full commercialization anticipated this fall. The Visiflex is designed to provide improved catheter flexibility for delivery of the Powerlink endoluminal stent graft device. An integrated radiopaque band marker on the outer sheath and molded component parts are expected to enhance catheter visibility and facilitate smoother withdrawal in difficult anatomies.
• E-Z-EM (Lake Success, New York), a manufacturer of contrast agents for gastrointestinal radiology, reported the launch of the CO2Efficient Endoscopic Insufflator, a new device for insufflating the upper and lower gastrointestinal tract with carbon dioxide gas. Based on the company’s PROTOCO2L device for CT colonography, CO2Efficient provides a way to adapt the use of CO2 gas insufflation to procedures such as colonoscopy, endoscopic retrograde cholangiopancreatography and enteroscopy.
• Estech (San Ramon, California) reported the market launch of AFfirm, an atrial fibrillation (AF) conduction block verification probe. AFfirm assesses the effectiveness of cardiac ablation treatments, which create new electrical paths in the heart, resulting in improved cure rates. The pacing probe’s flexible design allows easy access to treatment sites, including minimally invasive or stand-alone treatments for AF.
• Focus Surgery (Indianapolis) reported that a clinical study for locally recurrent prostate cancer following radiation failure with High Intensity Focused Ultrasound (HIFU) using the Sonablate 500 is now enrolling patients at the London Health Sciences Centre (London, Ontario). The purpose of the study is to determine the ability of HIFU to destroy prostate cancer tissue in patients with local recurrence after radiation failure. Developed by Focus Surgery and manufactured by Misonix (Farmingdale, New York), the Sonablate 500 is the only HIFU device in Canada that can treat prostates with height dimensions greater than 25 mm and does not require a preliminary transurethral resection of the prostate, a surgical procedure.
• GE Healthcare (Waukesha, Wisconsin) reported the introduction of Logiq e, the newest member of GE’s Compact Series of ultrasound systems, designed to support real-time clinical decisions in emergency settings. GE debuted Logiq e at the Society for Academic Emergency Medicine annual meeting in San Francisco. The company said the easy-to-use ultrasound system offers advanced connectivity features that streamline clinical workflow by allowing clinicians to take the ultrasound exam to the patient. Logiq e is built on GE’s software-based TruScan architecture and miniaturization technologies with the image quality and performance of a full-size system. Features like Coded Harmonics, Automated Image Optimization, Easy 3D and LogiqView help in diagnosing a diverse array of patient conditions encountered in the emergency department. Raw data acquisitions and automated applications translate to less time obtaining diagnostic information. A quick, 20-second boot up and single-hand probe connections make the Logiq e ready to scan when seconds count. Separately, GE Healthcare reported that it has initiated a “first-in-man” clinical study of a new molecular imaging agent to be used with positron emission tomography (PET), the study designed to validate the agent’s ability to provide information on the nature and extent and nature of cancer. Specifically, GE said, the molecular imaging agent has a biological mechanism to track the process of angiogenesis, which the company said could help physicians identify the location and growth patterns of tumors earlier, thereby leading to earlier correction of drug therapy in either type or dosage. “That’s our hope: to reverse adverse effects, select the right therapies and doses of therapies, help longevity,” Don Black, MD, head of research and development at GE Healthcare’s Medical Diagnostics division, said. The current “gold standard” for tracking the progression of cancer is to administer several cycles of chemotherapy and repeat imaging of the patient to determine if the tumor has shrunk, Black said. This new agent could specifically help clinicians to monitor the effectiveness of anti-angiogenic cancer drugs, which Black notes is “the basis for a lot of cancer therapy right now.”
• Genzyme (Cambridge, Massachusetts) reported the availability of two new molecular tests for acute myelogenous leukemia with the launch of FLT3 Mutation Analysis and WT1 RQ-PCR. FLT3 mutations are considered a prognostic indicator of poor survival and response to standard chemotherapies. Designed to detect minimal residual disease, the WT1 RQ PCR test allows physicians to monitor AML patients for early relapse during and following therapy. Together, these tests may enable oncologists to better manage their patients, the company said.
• Imaging Diagnostic Systems (Fort Lauderdale, Florida) reported that the CT Laser Mammography (CTLM) system was recently featured in two European publications. An article appearing in a special edition of the European Congress of Radiology newsletter, Newstyle, discussed the principles of CTLM technology and research conducted at the Medical University of Vienna (Austria) with the CTLM system, as well as future applications. “Through molecular imaging with laser, an improved diagnosis of breast tumors has become possible – and without the slightest exposure to radiation,” the author stated. And European Hospital’s April/May 2006 issue featured an article, “CTLM Seeing through the dense breast.” Imaging Diagnostic Systems is seeking FDA premarket approval for its CTLM system to be used as an adjunct to mammography.
• Matritech (Newton, Massachusetts), a developer of protein-based diagnostic products for the early detection of cancer, said that independent investigators have reported that certain tests, such as the NMP22 BladderChek Test, could save lives and reduce expense when screening high risk populations for bladder cancer. Yair Lotan, MD, of the University of Texas Southwestern Medical Center presented the findings at the American Urology Association annual meeting. The analysis indicated urine-based bladder cancer markers could reduce mortality and save costs in a high-risk population, if the cost of the urine test is less than $126. Overall, Lotan’s model projected a gain of three life years and $101,000 saved from reduced treatment costs per 1,000 people screened based on a population with 4% incidence of bladder cancer. Researchers noted that adjusting for other causes of mortality did not vary the results significantly, and screening vs. not screening is more cost-effective as long as the cancer incidence is greater than 1.6%. The NMP22 BladderChek Test, a noninvasive assay, is the only in-office test approved by the FDA for both the diagnosis and monitoring of bladder cancer.
• MedicalCV (Inver Grove Heights, Minnesota) reported that it has submitted a 510(k) application to the FDA seeking clearance for its Atrilaze minimally invasive system for the potential treatment of atrial fibrillation (AF) in a closed-chest, beating-heart setting. The submission marks a key point in the company’s transition from a previous focus on heart valve therapy via ablation. The Atrilaze is a laser-based system designed to enable access to and ablation of cardiac tissue including AF, an erratic heartbeat and is the most commonly occurring cardiac arrhythmia. AF alters normal cardiac function, is a major precursor to congestive heart failure and is associated with an increased incidence of stroke. According to a company statement, there currently are four primary treatments for AF utilizing drugs, implantable devices, catheter-based treatments and open-chest surgery. The company said it believes its Atrilaze system will allow surgeons to complete an ablation procedure that will produce lesions that closely mimic those obtained by using the classic Maze surgical procedure, which is the current standard of care.
• Medtronic (Minneapolis) reported commercial release of the Prostiva RF therapy system for the treatment of symptomatic benign prostatic hyperplasia (BPH). Prostiva RF therapy delivers low-level radio frequency energy through the urethra - now with a re-engineered handpiece and generator - to destroy a precisely targeted area of an enlarged prostate. Prostiva RF therapy was formerly called Transurethral Needle Ablation (TUNA). In contrast to BPH drugs, Prostiva RF therapy is intended as a one-time treatment for symptomatic BPH that improves urine flow and carries a low risk of sexual side-effects.
• Nasal drug delivery specialist OptiNose (Oslo, Norway) reported the presentation of new data on its breath-actuated powder and liquid drug delivery devices at Drug Delivery 2006 in San Diego. Deposition data for the breath-actuated powder delivery device in nine volunteers show a statistically significant increase (400%) in drug deposition in the upper posterior segment compared to traditional nasal spray pumps. The ability to deliver drug to the upper posterior part of the nose also enables the OptiNose devices to be used for targeted nose-to-brain delivery of CNS compounds for treatment of neurological diseases, the company said.
• Paradigm Spine (New York) said spine surgeons Dieter Adelt, MD and Rudolf Bertagnoli, MD, reported results of separate studies of the company’s coflex spinal implant at the annual Spine Arthroplasty Society meeting in Montreal. The investigational device is a U-shaped titanium alloy surgical implant indicated for use in patients with moderate to severe spinal stenosis, with neural element compromise, resulting in claudication and/or radicular symptoms isolated to 1 or 2 levels, in the region of L1 to L5. Adelt, a neurosurgeon at the Ostseeklinik (Damp, Germany), implanted 240 patients with the coflex interspinous device. His study evaluated 200, or 83%, of the patients. Spinal stenosis was found in 76% of the study group. Of these, Adelt said that 143 (86%) experienced relief in severe low back pain sufficient to significantly increase their walking distance. Bertagnoli, a surgeon at the ProSpine Centers (Straubing/Bogen, Germany), presented results of a 12-month follow up on 46 patients treated with the coflex interspinous implant. The patients had been diagnosed with secondary spinal canal stenosis, either with or without hypertrophic facet joints. A total of 60 devices were implanted. He reported that the results showed consistent reductions in six- and 12-month post-operative disability and pain scores compared with preoperative scores.
• Polymer Technology Systems (Indianapolis) is launching globally what it called “the world’s first direct low-density lipoprotein [LDL] cholesterol test” for use at the point of care, riding a trend toward healthcare self-management, which increasingly means self-monitoring. While the product is ultimately planned to be offered over the counter (OTC), currently it is CLIA-waived, FDA-approved and reimbursed by the Centers for Medicare & Medicaid Services (Baltimore) for use by physicians, pharmacies and other healthcare providers. It must still go through FDA approvals before being offered OTC. “The LDL [number] is the ‘Holy Grail’ of lipid testing, and that’s simply because it is the bad cholesterol,” CEO Robert Huffstodt said. “That’s why [physicians] are going to put you on a statin drug, and until our technology was available, there was nothing at point of care that would give you a direct reading.” The standard is to calculate LDL via the Friedewald equation, which Huffstodt said has been used since the early 1970s. While that equation provides an approximate reading, he said the test is “not good if your [triglycerides] are too high or too low, and it requires fasting to be completely accurate. We’ve made all that ancient history with this product,” he said, noting that POC testing is all about “bringing testing closer to the consumer, the patient.”
• Raymedica (Minneapolis) said that results from a 10-year clinical evaluation of patients implanted with the first generation PDN Prosthetic Disc Nucleus technology indicate the patients improved or maintained their range of motion and experienced early and sustained pain reduction. The findings of the retrospective analysis were presented at the Spine Arthroplasty Society meeting in Montreal. Raymedica’s PDN technology is a pre-formed hydrogel encased in a polyethylene jacket that has flexibility to facilitate delivery through a standard posterior approach and allows conformability to adapt to the human intervertebral disc space.
• Regeneration Technologies (Alachua, Florida), a processor of orthopedic, cardiovascular and other biologic implants, said it officially launched its Adjustable Bone Tendon Bone (BTB), the first in a new line of assembled tendon implants, at the Arthroscopy Association of North America annual meeting in Hollywood, Florida. The adjustable implants provide surgeons with an equivalent alternative to natural bone tendon bone grafts in strength and biocompatibility. The Adjustable BTB offers the flexibility of soft tissue grafts with bone tendon bone fixation. Features include pre-drilled suture holes and a pre-attached bone block for quick preparation. Surgeons can size the Adjustable BTB to fit any joint aperture. The Adjustable BTB is delivered to surgeons sterilized through RTI’s BioCleanse process and is covered by multiple U.S. and international patents pending.
• Smiths Medical (St. Paul, Minnesota), part of the global engineering business Smiths Group, reported that it has launched the LockIt Plus Catheter Securement Device, a new catheter fixation product designed to secure regional anesthesia catheters at skin level and prevent migration. The LockIt Plus consists of a large adhesive pad with an easy-to-peel backing that makes application easy and ensures adherence to the skin, and a transparent locking mechanism that allows clinicians to view the catheter exit site. After an epidural catheter is inserted into a patient, a LockIt Plus device is threaded over the catheter and adhered to the patient over the insertion site. Once adhered, the clear latch is closed to fixate the catheter to the skin. The device is available for catheters used with 16 and 17 gauge epidural needles. The same device for use with 18 guage needles will be released in the near future.
• Stereotaxis (St. Louis) reported the completion of a proof-of-concept demonstration of a magnetically enabled endocardial injection catheter developed in collaboration with the Biologics Delivery Systems Group of Cordis (Miami Lakes, Florida). The procedure, performed by Emerson Perin, MD, of the Texas Heart Institute, St. Luke’s Hospital (Houston), involved the remote magnetic steering of the Stereotaxis Niobe Magnetic Navigation System, the electromechanical mapping features of the Noga XP Cardiac Navigation System and a uniquely designed, magnetically enabled injection catheter. Performing the entire procedure remotely from the control room, Perin mapped the left ventricle and identified and easily navigated the magnetic injection catheter to 15 targeted injection sites in the left ventricle. He was able to obtain excellent injection delivery, including delivery to the most challenging ventricular locations.
• St. Jude Medical (St. Paul, Minnesota) reported FDA approval of its newest devices for treating patients with heart arrhythmias and heart failure. The Epic II ICD (implantable cardioverter defibrillator) and the Epic II HF CRT-D (cardiac resynchronization therapy defibrillator) devices feature enhanced telemetry speed for faster device communications and a “patient notifier” that gently vibrates to alert patients of critical changes in device function. The Epic II devices also include SenseAbility technology designed to allow optimizing of sensing parameters that may protect against inappropriate ICD shocks; AutoIntrinsic Conduction Search, intended to promote more natural heart function and minimize ventricular pacing; and DeFT Response technology to help physicians manage patients who require higher levels of defibrillation.
• Wright Medical Group (Arlington, Tennessee), a global orthopedics company, reported the launch of its next generation of OdysseyDistal Cut First (DCF) instruments for minimally invasive total knee replacement procedures. The instruments are reduced in size for minimally invasive surgery (MIS). The multi-function design requires fewer intraoperative steps than traditional instruments for increased surgical efficiency. The instrumentation’s reduced size avoids damage to the surrounding soft tissues. These features work together to offer increased surgical efficiency, the company said. The OdysseyDCF MIS instruments are designed for use with Wright’s Advance series of knee products, designed to provide more natural joint function.